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Purpose: To assess the subjective eye drop experience of patients with dry eye disease (DED) over approximately 1 hour after a single dose of two formulations of reproxalap versus lifitegrast. Methods: Two formulations of topical ocular reproxalap 0.25% were evaluated versus lifitegrast ophthalmic solution 5% in patients with DED in a single-center, double-masked, active-comparator, single-dose crossover clinical trial. Nineteen patients had test article topically administered to both eyes. Treatments were administered 2 to 4 days apart. Comfort assessments, including ocular discomfort, blurry vision, and dysgeusia assessments; ocular descriptive assessments; quality of life assessments; and overall experience questions were completed after each treatment over one hour, beginning at 90 seconds. Results: Both reproxalap formulations scored better in ocular discomfort score (ODS), blurry vision, and dysgeusia assessments than lifitegrast at each timepoint and cumulatively over all time points after instillation. There were lower rates of negative responses for both reproxalap formulations compared to lifitegrast across ocular discomfort, blurry vision, and dysgeusia assessments, and the durations of negative responses were shorter with reproxalap than with lifitegrast. The reproxalap groups experienced fewer quality of life impacts. No significant safety findings were observed following reproxalap or lifitegrast administration. Conclusion: The reproxalap eye drop experience over 1 hour after instillation was superior to that of lifitegrast. There were no statistically significant differences between reproxalap groups for ODS, blurry vision, or dysgeusia. The improved performance of reproxalap with regard to the most commonly reported side effects of lifitegrast (ie, ocular discomfort, blurry vision, and dysgeusia) may result in greater patient adherence and lower discontinuation rates. [ABSTRACT FROM AUTHOR]

Purpose: To report the subjective assessment of topical self-administered, cadaver-derived corneal epithelial stem cell supernatant for treatment of severe dry eye disease (DED). Methods: Thirty-four eyes of 17 patients with advanced DED as defined by Standardized Patient Evaluation of Eye Dryness (SPEEDTM) questionnaire ≥ 14, Ocular Surface Disease Index (OSDI©) score ≥ 40 and documented attempt of at least six conventional dry eye therapies were enrolled into a prospective clinical trial at a single private practice institution. Treatment consisted of patient self-administered topical instillation of the corneal epithelial stem cell-derived product four times daily in both eyes for 12 weeks. Patient-reported outcome measures (PROMs) were taken with the SPEEDTM questionnaire (the main outcome variable), OSDI© score and visual analog score (VAS; UNC Dry Eye Management Scale©), and objective clinical measurements were taken with best-corrected visual acuity (BCVA), corneal topographic index measurements and tear film osmolarity. These measurements were compared at baseline versus the endpoint at completion of the 12-week treatment. Results: All 34 eyes tolerated the treatment without any adverse events or significant side effects. Compared with baseline, both the SPEEDTM questionnaire and the VAS significantly improved at the conclusion of the 12-week treatment (p = 0.0054 and p = 0.0202, respectively). The OSDI© improved by an average of 10.9 points after the treatment but was not statistically significant (p = 0.1409). There were no significant changes in any of the objective clinical measurements. None of the study subjects failed to complete the treatment course, experienced decrease in any of the PROMs or lost one or more lines of BCVA during the follow-up period. Conclusion: Topical corneal epithelial stem cell-derived supernatant that can be self-administered by the patient shows promise at improving patient symptoms and quality of life in the setting of severe DED that is unresponsive to conventional therapies. [ABSTRACT FROM AUTHOR]

Purpose: To establish the prevalence of ocular involvement in a Colombian population with rheumatologic diseases. Design: Observational cross-sectional study. Methods: We included a probabilistic sample size of 797 patients who attended a rheumatologic disease center in Bogotá, Colombia. Statistical analysis with descriptive measures and Chi-square independence test between rheumatologic diseases and ophthalmological symptoms and diseases was performed. Results: Eighty-four percent of the population were women, and the mean age was 54.61± 15.64 years. The most common condition was rheumatoid arthritis (33.37%), followed by fibromyalgia (22.71%), Sjögren Syndrome (19.72%), and systemic lupus erythematosus (9.91%). Almost 7% of the patients presented polyautoimmunity. Thirty-five percent of the patients reported one or more ophthalmological symptoms, being dry eye sensation the most common (30.86%), followed by ocular pain (2.76%), red-eye, and decreased visual acuity (both 2.63%). Similarly, 21.45% of the patients presented one or more ophthalmological diagnoses, being keratoconjunctivitis sicca the most common (15.93%), followed by cataract, uveitis (1.38% each), and scleritis (1.25%). Conclusion: Almost a third of the patients reported any ocular involvement. It is crucial to be aware of the most common ophthalmic manifestations among the different rheumatologic diseases in our population, to offer early specialist referral and timely treatment. [ABSTRACT FROM AUTHOR]

Purpose: To assess the impact of dry eye disease (DED) on work productivity in Saudi Arabia and investigate its effect on daily activities. Patients and Methods: We conducted a cross-sectional study on male and female Saudi workers age 20 years or older. The data were collected via self-administered questionnaires distributed electronically through social media. We used the Ocular Surface Disease Index questionnaire to diagnose DED patients and assess their DED severity as mild, moderate, and severe. Results: A total of 463 respondents qualified for the study. All patients in the DED groups reported a loss of work productivity. Most patients in the severe DED group (59%) reported difficulty focusing on work due to DED, whereas 17.1% of patients with mild DED and 22.7% with moderate DED reported the same. These findings indicate significantly worsening productivity as DED progresses in severity (p< 0.05). Participants with severe DED reported significantly more affected work hours weekly (35.8%) than participants with moderate (6.1%) and mild DED (7.1%). Conclusion: DED has a significant impact on work productivity, with the most pronounced effect among office workers. It is essential to screen office workers for DED and enhance the awareness of its effect on work productivity among the workforce and healthcare providers. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effectiveness of a combination of intense pulsed light and low-level light therapy (IPL/LLLT) for the treatment of dry eye. Study Design: Retrospective before-after single-center clinical study. Materials and Methods: Patients diagnosed with dry eye, refractory to conventional treatment, underwent four sessions of combined IPL/LLLT over 3 months. The Ocular Surface Disease Index (OSDI) questionnaire, non-invasive breakup time (NIBUT), tear film osmolarity and meniscus height were measured 6 months before intervention, at baseline, post-intervention (3 months), 9 and 15 months. Results: NIBUT, osmolarity and meniscus height significantly worsened during the 6 months before treatment, whereas symptoms did not change. OSDI scores significantly improved at post-intervention (MD = − 44.0, 95% CI − 38.1, − 50.0), and then increased again until the at last follow-up, but still significantly different from baseline (MD = − 30.0, 95% CI − 23.4, − 36.8). The three clinical signs showed a similar pattern, with one-year improvements of 3.6 seconds for the NIBUT (95% CI 3.1, 4.2, p < 0.001), 28 mOsm/L for osmolarity (95% CI 23.6, 32.4, p < 0.001) and 0.03 mm for meniscus height (95% CI 0.02, 0.04, p < 0.001). No adverse effects were observed. Conclusion: IPL/LLLT is safe and produces an important reduction in symptoms and signs of dry eye disease, still relevant one year after the end of treatment in a sample with high symptoms' severity. Therefore, it represents a promising treatment option for patients who do not improve with conventional treatment. Randomized trials are needed to determine the added benefit provided by LLLT. [ABSTRACT FROM AUTHOR]

The pandemic of coronavirus disease 2019 (COVID-19) has led many countries of the world to impose a series of containment measures such as lockdowns (mass quarantines), curfews or similar restrictions (eg, stay-at-home orders, or shelter-in-place orders). All these restrictions were established in order to limit spread of COVID-19. Thus, approximately 3.9 billion people worldwide were under lockdown by early April 2020. During this time (home confinement), some solutions have been proposed by experts to improve work and school productivity, including smart working and online school lessons. However, many of the restrictive measures are likely to act as predisposing factors for dry eye disease (DED), directly or related to sick building syndrome (SBS). Herein, we discuss the implications of quarantine measures on eye health, in particular on DED associated with SBS, and introduce some potential preventive strategies for lockdown-related ocular surface disorders. Several risk factors are implicated in their pathogenesis, including environmental changes (eg, air quality) and modifications in personal behaviors (eg, the abuse of digital devices, malnutrition, and sleep/psychiatric disorders). Considering a number of predisposing factors for DED, it is possible to state that patients under lockdown are at risk of ocular surface alterations. Accordingly, the COVID-19 pandemic era is expected to determine an increase in dry eye patients all around the world (a new phenomenon that we propose to name the "quarantine dry eye") in the event that the restrictive measures will be recursively extended over time. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a complex multifactorial disease showing heterogenous symptoms, including dryness, photophobia, ocular discomfort, irritation and burning but also pain. These symptoms can affect visual function leading to restrictions in daily life activities and reduction in work productivity with a consequently high impact on quality of life. Several pathological mechanisms contribute to the disease: evaporative water loss leads to impairment and loss of tear homeostasis inducing either directly or indirectly to inflammation, in a self-perpetuating vicious cycle. Dysregulated ocular immune responses result in ocular surface damage, which further contributes to DED pathogenesis. Currently, DED treatment is based on a flexible stepwise approach to identify the most beneficial intervention. Although most of the available treatments may control to a certain extent some signs and symptoms of DED, they show significant limitations and do not completely address the needs of patients suffering from DED. This review provides an overview of the emerging experimental therapies for DED. Several promising therapeutic strategies are under development with the aim of dampening inflammation and restoring the homeostasis of the ocular surface microenvironment. Results from early phase clinical trials, testing the effects of EnaC blockers, TRPM8 agonist or mesenchymal stem cells in DED patients, are especially awaited to demonstrate their therapeutic value for the treatment of DED. Moreover, the most advanced experimental strategies in the pipeline for DED, tivanisiran, IL-1R antagonist EBI-005 and SkQ1, are being tested in Phase III clinical trials, still ongoing. Nevertheless, although promising results, further studies are still needed to confirm efficacy and safety of the new emerging therapies for DED. [ABSTRACT FROM AUTHOR]

Dry eye and migraine are common diseases with large societal and economic burdens that have recently been associated in the literature. This review outlines the link between dry eye and migraine, which may have implications for reducing their respective burdens. We highlight possible shared pathophysiology, including peripheral and central sensitization, as the potential link between dry eye and migraine. Finally, therapies targeting similar pathophysiological mechanisms between dry eye and migraine are discussed. [ABSTRACT FROM AUTHOR]

Background: The neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) have been used as indicators of inflammation, however, their roles in dry eye disease (DED) patients require advanced study.Materials and Methods: A total of 104 DED cases and 97 healthy controls from January 2020 to May 2020 were enrolled in this study. The dry eye related clinical variables, including Schirmer I test, tear break-up time (TBUT), corneal fluorescein staining (CFS) and Ocular Surface Disease Index (OSDI), were detected in all the participants. Besides, the NLR and PLR pattern in DED cases were detected and their potential value as inflammatory predictors of DED were evaluated. In advanced analyses, the correlation between NLR and DED severity was examined.Results: The NLR and PLR were 2.59 ± 1.25 and 117.48 ± 54.68 in the DED group, respectively, while they were 2.20 ± 1.24 and 115.48 ± 54.33 in the control group, respectively. The NLR was higher in the DED group (p = 0.027), however, PLR was not significantly different compared with the control group (p = 0.951). In advanced analyses, it was found that more severe TBUT, CFS, and OSDI scores were detected in the high NLR group (NLR ≥2.145, p = 0.003, 0.013, and 0.017, respectively) compared with the low NLR group (NLR <2.145).Conclusion: The NLR value, but not PLR, of DED patients was higher than that of healthy controls. The NLR could be used as an inflammatory predictor to estimate the severity of DED. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a condition frequently encountered in ophthalmology practice worldwide. The purpose of this literature review is to highlight the worldwide trends in DED diagnosis and therapy amongst practitioners and determine if a more uniform approach to manage this multifactorial condition has developed over the past two decades. A manual literature search utilizing PubMed was conducted to obtain papers with survey results relating to ophthalmology and optometry diagnosis and treatment of dry eye from January 2000 to January 2020. This did not include data from clinical trials as we were only interested in community clinical practice trends. The terms "dry eye" and "survey" were searched in combination with one or more of the following words or phrases: prevalence, diagnosis, treatment, therapy, etiology, risk factors, therapy, and quality of life. Papers were selected based on their direct applicability to the subject and were only included if they contained relevant survey data from community practitioners. The available literature suggests common trends worldwide in the diagnosis and treatment of DED. These trends have not modified substantially over the past two decades. Practitioner education on the benefits of measuring tear film homeostasis could increase its use as a diagnostic tool to complement current tools. Of the results found, 75% of the papers were published after 2006 and only one paper after 2017. More recent survey results are required to determine if research into DED pathophysiology is altering the current trend in DED management. [ABSTRACT FROM AUTHOR]

Background: OTX-101 is approved for treatment of keratoconjunctivitis sicca (KCS). We present results of a phase 3 worse-eye efficacy analysis and 1-year safety extension. Methods: During the double-masked treatment phase, patients with bilateral KCS were randomized 1:1 to 12 weeks OTX-101 or vehicle 1 drop per eye twice daily. Efficacy assessments included Schirmer's test and corneal and conjunctival staining. All patients who completed the treatment phase were eligible for enrollment in the open-label extension and received 1 drop OTX-101 twice daily for up to 52 weeks. Safety endpoints included adverse event (AE) monitoring, Snellen visual acuity (VA), intraocular pressure (IOP), slit-lamp examination (SLE), and dilated fundoscopy. Results: Overall, 745 and 258 patients enrolled in the treatment and safety extension phases, respectively. At 12 weeks, number (%) of patients with Schirmer's score increase of ≥ 10 mm from baseline was 76 (20.5%) vs. 42 (11.3%) for OTX-101 vs. vehicle (P=0.0005). OTX-101 significantly improved total conjunctival staining vs. vehicle at week 12 (least squares mean change from baseline − 1.65 [0.12] vs. − 1.12 [0.12], P=0.0013), and number (%) of patients with clear central corneas vs. vehicle at week 12 (222 [64.0%] vs. 199 [55.3%], P=0.0179). In the 1-year safety extension, AEs were mostly mild; instillation site pain was most common in 59 (22.9%) patients (17 [13.2%] vs. 42 [32.6%] patients receiving prior OTX-101 and vehicle). No safety concerns were raised by VA, IOP, SLE, and fundoscopy. Conclusion: OTX-101 efficacy was confirmed in the eye with lower baseline Schirmer's score. OTX-101 was well tolerated long term. Clinical Trial: Registered at ClinicalTrials.gov on July 27, 2016. NCT02845674 https://clinicaltrials.gov/ct2/show/NCT02845674?term=OTX-101&draw=2&rank=1. [ABSTRACT FROM AUTHOR]

Purpose: To assess the effect of vectored thermal pulsation treatment (VTP) on visible meibomian gland structure (VGS) in patients with meibomian gland dysfunction (MGD). Setting: Private group practice (A.T.E.). Design: Retrospective, single-blinded cohort study. Methods: Visible meibomian gland structure was evaluated at baseline and at 1-year in treatment (30 patients, 48 eyes) and control (13 patients, 22 eyes) groups. Meibography images were captured using dynamic meibomian imaging. Images were assessed using a novel morphometric analysis technique and analyzed for change in area of VGS (pixels). Additional outcomes measured include tear break up time, corneal staining, tear osmolarity, matrix metalloproteinase-9 (MMP-9), meibography grading, and meibomian gland evaluation. Results: As high as 69% of eyes in the treatment group showed an improvement in VGS versus 27% of eyes in the control group. As high as 31% of eyes in the treatment group showed a decline in VGS versus 73% of eyes in the control group. TBUT (p = 0.0001), corneal staining (p = 0.0063), and meibomian gland evaluation scores (p = 0.0038) all significantly improved after VTP treatment. However, SPEED scores, MMP-9, tear osmolarity, and meiboscale scores were not significantly improved 1-year post treatment. Conclusion: A morphometric analysis protocol of meibography provides clinically meaningful information that is undetectable with the standard semiquantitative method of grading meibomian gland structure. This is the first report indicating that gland structure may increase post-VTP relative to untreated controls, thus presenting significant implications regarding benefits and timing of VTP therapy. The described protocol is currently more appropriate for research than for clinical practice. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a multifactorial disease of the ocular surface and tear film that has gained awareness as a public health problem. Characteristics of DED include tear film instability, hyperosmolarity, and ocular surface inflammation, which can occur independently or may be a sequela of numerous ocular diseases, ocular surgery or contact lens wear. Much has been learned about the impact of the disease to help affected individuals who report symptoms of poor vision, pain, and tearing. Recently, new research highlights the importance of the role of ocular surface inflammation and damage in DED—leading to a vicious cycle of inflammation as well as loss of tear film homeostasis. DED immunopathophysiology is characterized by four stages: initiation, amplification, recruitment, and re-initiation. Cyclosporine is proven to be a valuable ophthalmic therapeutic for DED through its immunomodulatory actions and regulation of the adaptive immune response. Cyclosporine mechanism of action is well described in the published literature and the myriad of benefits in all four stages lend a broad-based immunomodulatory function particularly suitable for addressing DED. Furthermore, cyclosporine has unique goblet cell density improvement capabilities as well as anti-apoptotic properties. Topical formulations of cyclosporine are centered around addressing the highly lipophilic nature of the molecule. The poor aqueous solubility of cyclosporine traditionally presented technical challenges in drug delivery to the ocular surface. Newer formulations such as cationic emulsions and nanomicellar aqueous solutions address formulation, tissue concentration, and drug delivery challenges. [ABSTRACT FROM AUTHOR]

Purpose: To compare the repeatability of keratometry between different instruments in patients with hyperosmolar tear film and a control group. Patients and Methods: Subjects with tear-film osmolarity of 316 mOsm/L or more in either eye or 308 m/Osm/L or lower in both eyes were assigned to the hyperosmolar and the control group, respectively. The test eye was the eye with higher osmolarity in the hyperosmolar group and randomly chosen in the control group. The repeatability of keratometry was compared between a reflectometry device (Haag-Streit Lenstar 900), a Scheimpflug device (Oculus Pentacam HR) and two optical coherence tomography (OCT) devices (Tomey Casia SS-1000 and Heidelberg Anterion), based on two measurements from each device. Results: The study included 94 subjects (31 hyperosmolar and 63 controls). Both OCT devices had higher mean differences of average simulated keratometry (SimK) vs the Lenstar in both groups, though all differences in means were < 0.07 D. The Casia had the highest mean vector difference of SimK astigmatism in the control group (differences in means < 0.11 D). These differences of the instruments were statistically significant (p < 0.02), except for the Anterion in the control group. With all subjects, the coefficient of repeatability varied from 0.1 to 0.3 for average SimK (highest for both OCT devices) and from 0.4 to 0.7 for SimK astigmatism (highest for the Casia). Similar results were found for total corneal power (OCT devices compared to the Pentacam). Conclusion: Both OCT devices show more variability in average SimK and the Casia more variability in SimK astigmatism compared to the Lenstar and the Pentacam. However, the results suggested that repeatability was not influenced by osmolarity. [ABSTRACT FROM AUTHOR]

Aim: To compare differences in clinical dry eye features and meibomian gland health status between dry eye patients from rural and urban populations in Ghana. Methods: We examined 211 (rural=109, urban=102) participants with subjective dry eye symptoms. Tear film break -up time (TBUT), Schirmer's test and ocular surface staining (OSS) were assessed. Symptoms were evaluated using the SPEED II questionnaire. Meibomian glands (MG) in the right eye upper (UL) and lower lids (LL) were imaged using a custom meibographer. MG area was determined by intensity threshold segmentation using Image J software. MG loss (MGL) was also graded based on Pult's grading scheme. Mann–Whitney, Spearman correlation, chi-square and odds analyses were performed; p< 0.05 was considered significant. Results: Rural participants showed greater SPEED scores, reduced TBUT, and lower Schirmer scores, p < 0.05. The proportion of rural participants with MGL were significantly more (82.3%) than urban participants (63.3%), p < 0.05. They also showed greater MGL than urban participants, p < 0.05. Chi-square test revealed significantly different meiboscale distributions (UL: χ2=13.58, LL: χ2=15.29) between the groups, p < 0.05. Overall significant relationships were observed between MGL and age [rs= 0.61], OSS [rs= 0.35], TBUT [rs= − 0.52], and Schirmer scores [rs= − 0.40], p < 0.05. Conclusion: The data suggest that the participants from the rural population have worse dry eye and meibomian gland health status than those from the urban population. The significant relationships between the various clinical variables suggest important links between MGD and DED. Subtle differences in the everyday working and living environment could likely account for the differences in the severity of DED and MGD between the two groups. And considering the increased pattern of urbanization, industrialization and modernization and the related environmental effects in Africa, future longitudinal studies on specific environmental risk factors or mediators of DED and MGD are necessary to ascertain the MGD and DED situation in Ghana and Africa at large. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate symptom relief in patients with dry eye disease (DED) following a single drop of propylene glycol-hydroxypropyl guar (PG-HPG) nanoemulsion (Systane® Complete) lubricant eye drops. Methods: This was a Phase IV, multicenter, open-label, interventional study in adult patients with DED of aqueous-deficient, evaporative, and mixed subtypes. Patients instilled one drop of PG-HPG in each eye at Day 1. Endpoints included change from baseline in dry eye symptom and soothing sensation scores on Day 1 at 0, 4, and 8 hours post-dose. Symptom scores were assessed on a 0– 10 scale (0=no symptoms; 10=worst imaginable symptom). Tolerability of the drop was assessed based on assessment score on Day 1 following instillation for overall cohort and by DED subtype. Results: A total of 134 patients received treatment (mean age: 56.6 years; female: 75.4%). Median changes from baseline at Day 1 in dry eye symptom scores were − 1.0 (95% confidence interval [CI]:-3.0,-1.0), − 2.0 (95% CI:-3.0,-2.0), and − 2.0 (95% CI:-2.0,-1.0) at 0, 4, and 8 hours respectively. Subgroup analysis showed a median change from baseline in dry eye symptom score of − 2 (95% CI:-3.0,-1.0) for aqueous-deficient and evaporative subtypes and − 1 (95% CI:-3.0,-1.0) for mixed subtype at 8 hours. Median soothing sensation scores were 3 at 0 and 4 hours and 3.5 at 8 hours, with a range of 0– 10. Median (range) tolerability assessment scores were 0 (0– 8) for burning sensation, stinging sensation, blurring, and 0 (0– 10) for foreign body sensation. Tolerability assessment scores by DED subtype confirmed that the majority of patients reported scores in the range of 0– 5 for all components and in all subgroups analyzed. Conclusion: Our study demonstrated that PG-HPG nanoemulsion provided instant/immediate and sustained symptom relief for 8 hours post-single application and was well tolerated in patients with DED, demonstrated by their responses on each of the assessment scales. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy and safety of an artificial tear combining the polymers carboxymethylcellulose (CMC) and hyaluronic acid (HA), to a formulation of CMC alone in subjects with dry eye. Methods: A preservative-free artificial tear (CMC-HA) was compared with an existing artificial tear (CMC). Subjects with mild-to-severe signs and symptoms of dry eye were enrolled in this double-masked, randomized, multicenter trial, and dosed at least twice daily for 90 days, with follow-up visits at Days 7, 30, 60, and 90. Ocular Surface Disease Index (OSDI) was the primary outcome measure. Secondary outcome measures were tear break-up time (TBUT), ocular surface staining, Schirmer test with anesthesia, and visual analog scale (VAS) scores of dry eye symptom severity and formulation acceptability. Safety measures included adverse events, biomicroscopy, and visual acuity. Results: A total of 460 subjects were enrolled across 45 sites (38 in Europe; 7 in Australia), of whom 454 were randomized to receive treatment. The per-protocol (PP) population consisted of 394 subjects, 364 (92.4%) of whom completed the study. In the PP population, the mean ± SD change from baseline in OSDI score at the primary timepoint, Day 90, was − 16.9± 17.5 for CMC-HA and − 16.0± 16.1 for CMC. CMC-HA was non-inferior to CMC based upon a confidence interval method. Both treatments significantly improved (P< 0.001) OSDI, symptom VAS scores, TBUT, and ocular surface staining from baseline at all follow-up visits, with minimal differences between groups. Greater reduction of overall ocular pain/discomfort was reported in subjects using CMC-HA versus CMC (P=0.048). Approximately 10% of subjects in each group reported treatment-related adverse events of generally mild to moderate severity. Conclusion: The new CMC-HA formulation was effective and well tolerated, and demonstrates a greater potential for symptom relief compared with CMC. These data support implementation of this formula for the management of dry eye patients. [ABSTRACT FROM AUTHOR]

Purpose: There is some evidence suggesting a different nature of response to selective laser trabeculoplasty (SLT) among different races. Therefore, we aimed to assess the short-term efficacy, safety and nature of outcome of SLT in Omani eyes. Patients and Methods: A retrospective review was performed of patients with open-angle glaucoma (OAG) or ocular hypertension (OHTN) who underwent a single session of 360-degree SLT between January 1, 2017 and December 31, 2018. The main outcome was mean IOP reduction and attainment of treatment success at 5 weeks and 12 weeks post treatment defined as at least 20% IOP reduction from baseline without further medications or interventions. Secondary outcomes were frequency of adverse events and factors predicting success. Results: A total of 33 eyes of 33 Omani patients who underwent treatment with SLT were analyzed. The nature of response to laser followed a gradual pattern as the mean IOP reduction from baseline was 20.2% (5.21 mm Hg, P < 0.001) at 5 weeks and further enhanced to 27.2% (6.95 mm Hg, P < 0.001) at 12 weeks. Short-term success was achieved in 51.5% and 72.2% of eyes at 5 and 12 weeks, respectively. SLT was most effective in OHTN subgroup and those with higher baseline IOP (both P < 0.001). Side effects were an infrequent occurrence, minor and transient. Conclusion: The short-term success of SLT in Omani eyes was clinically relevant and comparable to the gradual pattern seen in patients of Indian ancestry. It is a safe therapeutic option in selective Omani eyes. [ABSTRACT FROM AUTHOR]

Purpose: To analyze the demographic patterns, clinical characteristics and etiologies of acute optic neuritis (ON). Methods: This retrospective observational study included patients with acute ON who presented to a university hospital in Bangkok, Thailand, between January 2010 and March 2020. The demographic details, clinical characteristics and etiologies of acute ON were evaluated. Results: A total of 171 patients were included in the study (78.4% [n=134] female; mean age 45 years [standard deviation 15.4 years]; 32.2% [n=55] bilateral involvement). The most common type of acute ON was idiopathic (51.5%), followed by neuromyelitis optica spectrum disorder (NMOSD, 30.9%), other autoimmune disorders (9.9%), myelin oligodendrocyte glycoprotein antibody-associated disorder (MOGAD, 5.3%), multiple sclerosis (MS, 1.8%), and postinfection (0.6%). In the other autoimmune disorders group, 2 patients developed systemic lupus erythematosus (1.2%), 2 Sjogren's syndrome (1.2%), 1 RA (0.6%), 1 anti-NMDAR (0.6%), 3 anti-Jo1 (1.8%), 2 c-ANCA (1.2%), 1 anti-centromere (0.6%), and 5 nonspecific autoimmune disorders (2.9%). In the idiopathic group, 38.6% developed single isolated ON, 1.8% relapsing isolated ON and 11.1% chronic relapsing inflammatory optic neuropathy. Conclusion: The most common form of acute ON in this study, similar to other Asian countries, was idiopathic. Idiopathic-ON shared some phenotypes with NMOSD and MOGAD. We also reported patients with anti-NMDAR, anti-Jo1, c-ANCA and anti-centromere disorders. Improvements in antibody detection have widened the range of possible etiologies of acute ON. The study highlighted the important role of antibodies in creating effective treatments in the future. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the efficacy of a micro-emulsion (ME) lipid layer artificial tear in improving tolerance of immunomodulator eye drops for the treatment of dry eye disease. Patients and Methods: A total of 33 patients with previously diagnosed dry eye disease were given the micro-emulsion lipid layer artificial tear in conjunction with either lifitegrast or cyclosporine. Patients were queried on their tolerance of the regimen by reporting VAS scores before starting the adjunctive eye drop, immediately after starting, and 2– 3 weeks later. Tolerance was statistically compared over time and with respect to previous medication compliance, timing of the adjunctive eye drop, age, gender, and ethnicity. Results: Across all patients, the VAS pre-treatment score (6.8 ± 0.6) was significantly higher than both the VAS 1-day post ME lipid tear instillation time point (3.0 ± 0.7) (post hoc Bonferroni, p < 0.001) and the VAS 2– 3-week post instillation time point (1.7 ± 0.7) (post hoc Bonferroni, p < 0.001), with the mean VAS score improving over time (post hoc Bonferroni, p < 0.028). Average VAS scores did not vary with respect to specific medical therapy or the timing of instillation of this artificial tear. Both the "at-risk" and "conversion" groups independently had significant improvements at both 1-day and 2– 3-week time points compared to baseline. Conclusion: The micro-emulsion lipid layer artificial tear was effective as an adjunctive eye drop to improve tolerance of lifitegrast and cyclosporine for patients with dry eye disease who were at risk of failing or had previously failed immunomodulatory therapy. [ABSTRACT FROM AUTHOR]

Purpose: To describe the prevalence of dry eye disease (DED) and its subtypes in elderly population with cataracts prior to surgery in Jakarta, Indonesia. Patients and Methods: Forty-nine eyes of 49 patients (16 males, 33 females; mean age: 66.6 years) planned for phacoemulsification surgery were consecutively recruited from two tertiary eye hospitals in this hospital-based cross-sectional study. Symptoms were assessed using the Ocular Surface Disease Index (OSDI) questionnaire, and the patient was defined as symptomatic if their OSDI score was ≥ 13. Objective examinations included the noninvasive tear film break up time (NIBUT) and Schirmer tests. The results were deemed abnormal if they were < 10 seconds and < 10 mm for NIBUT and Schirmer, respectively. Results: Participants were classified into four groups: DED (positive symptoms and short NIBUT), preclinical dry eye (positive symptoms without short NIBUT), predisposition to dry eye (short NIBUT without symptoms), and normal group. Median OSDI score was 12.5 (0– 45.0), NIBUT was 10.4 (5.1– 28.9) seconds, and Schirmer score was 8.0 (2.0– 28.0) mm. The prevalence of DED, preclinical dry eye, and predisposition to dry eye were 22.5%, 22.5%, and 26.5%, respectively, while the other 28.5% subjects were normal. The DED group had significantly lower Schirmer test results (4.0 [2– 17] mm) compared to all other groups. Older age (> 70 years) was associated with poorer NIBUT and Schirmer test results and a significant difference between age groups was observed, especially in males. Conclusion: Dry eye is a common problem among the elderly population with cataracts in Indonesia. Almost half of the subjects presented with dry eye symptoms and either categorized as DED or preclinical dry eye, while more than one quarter were predisposed to dry eye. Care must be taken prior to cataract surgery to rule out existing dry eye with additional attention on those presenting without any symptoms as dry eye may develop after surgery. [ABSTRACT FROM AUTHOR]

Purpose: To compare the efficacy of the new lubricating product VisuEvo® (VSE) vs Cationorm® (CTN) in patients with dry eye disease (DED). Methods: Seventy-two patients with evaporative (n=54) and non-evaporative DED (n=18) were included in a multicenter, double-blind, 12-week cross-over study to receive VSE (6 weeks) and CTN (6 weeks) in randomized sequence. After baseline, two visits were performed during each period (intermediate and final visit, respectively at 2 and 6 weeks from the beginning of each period). Primary (tear break-up time, TBUT) and secondary endpoints (Schirmer I, Ferning, blink rate, osmometry, cytokine and lipid expression, ocular surface staining, patient satisfaction, and OSDI score) were compared. Results: Sixty-three patients were evaluated for efficacy and 68 patients for safety. The intergroup differences for mean TBUT values were not significant at any study visit (baseline 3.2 ± 1.5 sec; intermediate visits 4.5 ± 1.9 and 4.5 ± 1.8 sec in VSE and CTN groups, respectively, p = 0.10; final visits 5.4 ± 2.4 and 6.0 ± 3.1, respectively, p=0.63). Also, the assessment of secondary endpoints showed no significant difference between the two groups. The two study treatments were equally effective in evaporative and non-evaporative DED. The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments. Conclusion: VSE was non-inferior to CTN in restoring tear film composition, increasing its stability and reducing ocular surface damage in evaporative and non-evaporative DED patients. Study Identifier: NCT03833882. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to compare the efficacy of two lipid-based lubricant eye drops in patients with lipid-deficient dry eye. Methods: This Phase IV, multicenter, prospective, double-masked study enrolled adults (aged ≥ 18 years) who had a tear film breakup time (TFBUT) of ≤ 15 seconds(s), and unanesthetized Schirmer I test of ≥ 3 mm to ≤ 12 mm in at least one eye, at both screening and baseline visits. Eligible patients (n=231) were randomized (1:1) and received either Systane® Balance (SYSB; n=117) or Refresh® Optive Advanced (RFO-Ad, n=114), four-times a day, for 35 days. The primary endpoint was non-inferiority for change from baseline in TFBUT at Day 35 (non-inferiority was established if the lower limit of the 95% confidence interval (CI) for the difference between the treatment groups was > – 1.0 s); secondary endpoints (test of superiority) were change in TFBUT and global ocular discomfort visual analog scale (VAS) score at Day 35. Other endpoints included the impact of dry eye on everyday life (IDEEL) treatment satisfaction scores (inconvenience and effectiveness) and safety. Results: At Day 35, the mean change from baseline in TFBUT was 0.998 s in the SYSB and 0.868 s in the RFO-Ad groups with a treatment difference: 0.130 s; (95% CI − 0.34, 0.60; P< 0.0001) demonstrating non-inferiority of SYSB to RFO-Ad. The global ocular discomfort VAS scores improved in both groups, with a mean change from baseline of – 9.7 and – 8.8 in SYSB and RFO-Ad groups (treatment difference – 0.8; P=0.62), respectively. No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad (P> 0.05 for treatment difference). Both treatments were well tolerated. Conclusion: SYSB lubricant eye drops were non-inferior to RFO-Ad for improvement in TFBUT in patients with lipid-deficient dry eye. Both lubricant eye drops improved TFBUT and ocular discomfort scores in patients with lipid-deficient dry eye. [ABSTRACT FROM AUTHOR]

Purpose: Dry eye disease (DED) is one of the most common ophthalmic disorders. Pathogenesis of the disease includes inflammation of the ocular surface and lacrimal gland. Two anti-inflammatory prescription treatments are currently available: cyclosporine ophthalmic emulsion 0.05% (CYC) and lifitegrast 5% ophthalmic solution (LIF). The objective of this survey-based study was to assess physician satisfaction with CYC and LIF for the treatment of DED. Methods: Physicians currently treating DED patients with CYC or LIF were asked to rate the experiences of their patients currently or formerly using CYC and LIF, and their own perspectives on the two treatments. Results: Twenty-one physicians participated in the survey, providing responses on behalf of 210 patients. Overall, physicians reported low levels of satisfaction with onset of action of CYC and LIF, and fewer than half considered either drug to be effective in managing symptoms or improving patient quality of life (QoL). Burning sensation and dysgeusia were the most frequently reported side effects. Onset of action and effectiveness after onset were the main switching drivers. Although two-thirds of physicians were satisfied with the overall effectiveness of CYC and LIF, all physicians agreed that more DED treatment options are needed, with > 50% strongly agreeing. Conclusion: Physicians perceived a gap in DED management with currently available topical anti-inflammatory agents. Although satisfaction with CYC and LIF was high, few physicians considered these medications to be effective in managing symptoms or improving QoL. [ABSTRACT FROM AUTHOR]

Keratoconjunctivitis sicca (KCS) is a multifactorial disease characterized by tear hyperosmolarity, inflammation, and ocular surface damage. Cyclosporine A (CsA) is used as an effective disease-modifying agent to improve the signs and symptoms of KCS by reducing inflammation, which interferes with tear production. This review provides an overview of efficacy, safety, and limitations of currently marketed topical CsA formulations—including CsA ophthalmic emulsion, cationic nanoemulsion, and aqueous nanomicelles—and highlights newer technologies for controlled ocular delivery of CsA and their clinical implications. Long available emulsion formulations of CsA are oil-based and have several limitations, including slow onset of efficacy and low intraocular penetration and bioavailability. Aqueous CsA nanomicelle carriers produce rapid improvement in objective signs of KCS such as corneal and conjunctival staining as early as 4 weeks and have acceptable safety profiles. CsA formulations using semifluorinated alkanes or polyaphrons are currently in clinical development, having recently completed Phase 2 studies. Other carriers for CsA currently in the preclinical phase include microemulsions, polymeric aqueous and lyophilized micelles, and hydrogels; these novel formulations have yet to undergo clinical trials. Formulations that improve tissue availability of CsA may be beneficial in clinical practice by providing faster onset of relief and improving patient adherence. [ABSTRACT FROM AUTHOR]

Purpose: To compare the prevalence of dry eye disease (DED) as determined by signs and symptoms in patients with a history of laser vision correction (LVC) or implantable collamer lens (ICL) implantation 5– 15 years ago with a matched control group with no history of refractive surgery. Patient and Methods: This was a cross-sectional case-control study. The subject population included patients who had LVC or ICL 5 to 15 years ago. The control group was age matched. A test eye was randomly chosen. Subjects were required to have good ocular health. DED was evaluated using categorical cut-off criteria for tear film osmolarity (measured in both eyes), the subjective Ocular Surface Disease Index (OSDI), the dynamic Objective Scatter Index (OSI), non-invasive keratography tear break-up time (NIKBUT), meibography, and the Schirmer 1 test. Results: The study included 257 subjects (94 LVC, 80 ICL, 83 control). The frequency of hyperosmolarity was significantly higher in the LVC group vs the control (73% vs 50%, p = 0.002), In contrast, the frequency of subjective symptoms tended to be lower in the LVC group than in the control group (19% vs 31%; p = 0.06). These differences were not seen between the ICL and control group. Conclusion: The results suggest that LVC may cause tear film instability as indicated by hyperosmolar tears up to 15 years after surgery, with few subjective symptoms of dry eye. This may have implications for IOL calculations for cataract or refractive lens exchange later in life. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by ocular signs and symptoms such as corneal and conjunctival damage, patient discomfort, and visual disturbance. The prevalence of DED ranges from 5%− 33%. Patients with DED may have a reduced quality of life due to their discomfort and visual disturbances. The multifactorial nature of DED requires a multi-targeted treatment approach to address the signs and symptoms. Treatment for DED should follow a step-wise approach beginning with education, dietary modification, and lid and lash hygiene, and progressing to pharmacologic and nonpharmacologic interventions. Ocular lubricants, a mainstay of DED therapy, provide temporary symptomatic relief for the patient, but do not address the underlying pathophysiology. Some currently available pharmacologic treatments that address the underlying pathophysiology of DED may have a delay of 3− 6 months in the onset of therapeutic effect; however, these treatment options may also have tolerability issues. These challenges highlight the need for newer pharmacologic treatments with an earlier onset of observable clinical effect and the potential for improved tolerability profile. Patient education is vital to DED management and should convey the complex and chronic nature of DED. It is important for the eye care practitioner to set realistic expectations with the patient when managing DED to help improve treatment success. This helps the patient understand the need for ongoing treatment and that results will likely not be seen immediately. This review covers the current management of DED, focusing on pharmacologic management, and offers recommendations for the practitioner to help facilitate realistic patient expectations for the treatment of DED. [ABSTRACT FROM AUTHOR]

Topical ocular preparations are widely recommended by health care professionals, or chosen by patients, to help manage dry eye disease (DED). The chronic and progressive nature of DED may result in the administration of topical products several times a day, over a period of many years. Given DED is a condition that by definition affects the ocular surface, it is important to understand how the repeated use of eye drops may impact the ocular surface, influence clinical signs, affect symptoms, and impact the overall disease process of dry eye. The component in topical preparations with the greatest potential to adversely affect the ocular surface is the preservative. This paper reviews the literature in relation to the use of preservatives in formulations for dry eye. The ocular effects of benzalkonium chloride (BAK) are summarised and compared to the performance of alternative preservatives and preservative-free formulations. Use of preserved and preservative-free drops in relation to the management of varying stages of DED is discussed. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a multifactorial disease of ocular surface and tear film, and is a common disorder treated by eye care providers. It is well established that ocular surface inflammation has an important role in the pathophysiology of DED and that anti-inflammatory cyclosporine A (CsA) improves the treatment outcomes of most patients with DED. The purpose of this review is to provide guidance for practitioners in the use of topical CsA for the management of DED to improve patient satisfaction and the quality of life. [ABSTRACT FROM AUTHOR]

Purpose: Evaluate the safety and efficacy of cryopreserved amniotic cytokine extract (ACE) in the treatment of subjects with dry eye disease (DED). Patients and methods: This was a retrospective, multicenter, chart review of adult patients with DED that instilled cryopreserved ACE drops twice-daily for 4 or 12 weeks. Patients had corneal fluorescein staining (0–20 range) and/or a lissamine green conjunctival staining score (0–18 range) of ≥3 and ≤9 in at least 1 eye and a score ≥40 (0–100 range) of eye dryness/irritation on a visual analog scale (VAS). Following completion of a treatment course, medical records were reviewed from the initiation of therapy (baseline), and at post-treatment visits (4 weeks, 8 weeks, and 12 weeks). Patient records for visual acuity, adverse events, corneal fluorescein staining, conjunctival lissamine green staining, and symptom scores of ocular dryness/irritation were reviewed for each visit, as available. Safety and tolerability were assessed through the evaluation of patient-reported adverse events recorded in the medical records. Results: A total of 54 eligible patients were identified at 7 clinical sites; 16 patients administered ACE drops for 4-weeks, and 38 patients instilled ACE drops for 12 weeks. Significant improvements in the mean changes from baseline were observed for corneal fluorescein staining, lissamine green staining, visual acuity (LogMar) and VAS ocular symptom scores at the 4-week post-treatment visit (p<0.01). Additional improvements continued out to the 12-week follow-up assessment visits. Two patients discontinued therapy due to reports of ocular burning or foreign body sensation. Conclusion: The cryopreserved ACE formulation was well-tolerated and effective in reducing the clinical signs and symptoms of DED. Conduct of a vehicle-controlled prospective study is warranted. [ABSTRACT FROM AUTHOR]

Objectives: Dry eye disease (DED) is a complex multifactorial condition of the ocular surface characterized by symptoms of ocular discomfort, irritation, and visual disturbance. Data previ-ously reported from this study showed an increase in prevalence and incidence of DED with age and over time. The objective of this study was to compare the ranking of DED prevalence among other ocular conditions that led patients to seek eye care. Methods: In this population-based study using the US Department of Defense Military Health System claims database of .9.7 million beneficiaries, indicators of DED and other ocular conditions were analyzed over time. The overall prevalence (2003–2015) and annual incidence (2008–2012) of DED and other ocular conditions were estimated using an algorithm based on two independent indicators derived from selected diagnostic and procedure codes and prescrip-tions for cyclosporine ophthalmic emulsion for DED and diagnostic codes for the indicators of other common ocular conditions. Results: In 2003–2015, the most common ocular conditions were disorders of refraction and accommodation (25.84%), cataracts (17.14%), glaucoma (7.27%), disorders of the conjunctiva (6.76%), other retinal disorders (5.94%), and DED (5.28%). DED was the fifth most prevalent ocular condition in women (7.78%) and ninth most prevalent in men (2.96%). In 2012, DED had the third highest annual incidence (0.87%), behind disorders of refraction/accommodation (1.87%) and cataracts (1.50%) .Conclusion: This study provided further epidemiologic evidence for DED as a commonly occurring condition that drives patients to seek treatment. [ABSTRACT FROM AUTHOR]

Purpose: Evaluation of the safety and effectiveness of a TearCare® retreatment in adult subjects with clinically significant dry eye disease (DED). Patients and methods: This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study. In the initial study, subjects with DED were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point. The TearCare® retreatment procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual meibomian gland clearance. The primary effectiveness end point was the change in tear break-up time (TBUT) from baseline to 1-month follow-up. Secondary end points included meibomian gland scores, corneal and conjunctival staining scores, and assessment of dry eye symptoms. Safety was evaluated through monitoring intraocular pressure, best-corrected visual acuity, and device-related adverse events. Results: Twelve subjects participated in the 6-month extension study. At 1-month clinic visit following retreatment, a significant improvement from baseline in mean (± SD) TBUT of 12.4 (±3.3) seconds was observed (P<0.001). Significant improvements in the mean change from baseline in meibomian gland scores, corneal and conjunctival staining scores, and symptoms of DED were also observed following retreatment. The second treatment was well tolerated. Conclusion: The findings of the extension study through 12 months suggest that a second TearCare® treatment after 6 months provides additional improvement in the signs and symptoms of DED. [ABSTRACT FROM AUTHOR]

Background: Dry eye disease (DED) is characterized by a loss of homeostasis of the tear film. It goes along with ocular symptoms, in which ocular surface inflammation and damage play etiological roles. High-mobility group box 1 protein (HMGB1) is a pro-inflammatory protein found in the tear fluid during conjunctivitis, blepharitis and DED. Glycyrrhizin binds to HMGB1, inhibiting cytokine activities, thus potentially improving DED. Aim: To assess the efficacy and tolerance of glycyrrhizin in moderate DED. Methods: Multicenter, open-label, prospective, nonrandomized clinical pilot study of glycyrrhizin 2.5% eye drops twice daily over 28 days in adult patients with moderate DED using standard evaluation parameters. Results: The overall mean age of the 37 patients included was 59.6±19.0 years, 70.3% of the patients were female and 77.0% of the patients had an Oxford score of II. After 28 days, 60.8% of the patients had an Oxford score of 0 or I; a significant mean improvement in the score of 0.97±0.86 (P<0.001) from 2.20±0.44 at day 1 to 1.23±0.88 at day 28 was observed. Tear break-up time and Schirmer scores had significantly improved while the number of patient-reported symptoms had significantly decreased (all P≤0.010). A large majority of patients still had a few spots on their naso-bulbar conjunctiva (86.1%), temporal-bulbar conjunctiva (81.4%) and cornea (84.7%). The investigators considered that DED had improved in 71.6% of the patients. Patients appreciated the eye drops for their efficacy and good tolerance profile, leading to a decreased use of artificial tears. No changes in intraocular pressure and visual acuity were observed; glycyrrhizin 2.5% eye drops were safe, with only one patient reporting a moderate, transient treatment-related contact allergy leading to the withdrawal of the patient. Overall, two patients reported three adverse events, two (moderate contact allergy in both eyes) were related to the eye drops and experienced by the same patient; treatment was stopped; the third event was not treatment-related. Conclusion: In this pilot study, glycyrrhizin 2.5% eye drops were well tolerated and provide a good clinical benefit to patients with moderate DED after 28 days of continued daily use. [ABSTRACT FROM AUTHOR]

Purpose: To compare dry eye (DE) diagnosis patterns by season in Miami vis-a-vis the US and examine differences in DE symptoms and signs by season in Miami.Patients and methods: US veteran affairs (VA) patient visits with ICD-9 codes for DE (375.15) and routine medical examination (V70.0) from 2010 to 2013 were retrospectively analyzed to evaluate the seasonal pattern of DE diagnosis. A total of 365 patients with normal ocular anatomy were prospectively recruited from the Miami VA eye clinic from 2014 to 2016 for the assessment of symptoms and signs.Results: While DE visit prevalence in Miami was about 10% lower than that of the rest of the country (22.5% vs 33.7%), Miami had roughly four times higher variability in DE visit prevalence throughout the year than the US. Peak values for DE symptoms in the Miami cohort aligned with peak DE prevalence seen in the retrospective sample, occurring in spring and fall. A similar, but less dramatic, pattern was noted with DE signs. The seasonal pattern in DE symptoms remained even after controlling for confounders including demographics and medication use.Conclusion: DE symptoms, and to a lesser degree signs, varied by month, with the highest severity of symptoms occurring in spring and fall, which corresponded with peak allergy season and weather fluctuations, respectively. These findings have important implications for season-specific diagnosis, treatment, and management of DE. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer's test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer's test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).Patients and methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0–100 visual analogue scale). Following a 14-day vehicle run-in, subjects were randomized in a 1:1:1 ratio to twice daily treatment with OTX-101 0.09%, OTX-101 0.05%, or vehicle for 84 days. Co-primary efficacy end points were changes, from baseline to Day 84, in the total lissamine green conjunctival staining score in the designated study eye and in the global symptom score (both eyes). Secondary end points included total corneal fluorescein staining score, tear breakup time, and Schirmer's test score.Results: In total, 455 subjects were randomized. Subjects treated with active drug experienced greater improvement in conjunctival staining than vehicle-treated patients (P<0.01 for both concentrations). All groups demonstrated improvements in global symptom score, but there were no differences among groups. Nominally significant differences were found between the active drug arms and vehicle for corneal staining scores and Schirmer's test scores. Most treatment-emergent adverse events were mild in severity; no serious ocular adverse events were reported.Conclusions: Both concentrations of OTX-101 met the co-primary sign end point (conjunctival staining) but not the co-primary symptom end point. OTX-101 0.09% demonstrated a notable impact on multiple signs of DED relative to vehicle and was well-tolerated. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to evaluate the safety and effectiveness of the TearCare® System in adult patients with clinically significant dry eye disease (DED). Patients and methods: This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects with DED were randomized to either a single TearCare treatment conducted at the clinic or 4 weeks of daily warm compress (WC) therapy. The TearCare procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual expression of the meibomian glands. WC therapy consisted of once daily application of the compresses to the eyelids for 5 minutes. Subjects were followed until 6 months post-treatment. The primary effectiveness end point was defined as change from baseline to 4 weeks for tear breakup time (TBUT). Secondary effectiveness end points included meibomian gland assessment, corneal and conjunctival staining scores, and assessment of dry eye symptoms using validated questionnaires. Safety was evaluated by collecting device-related adverse events, intraocular pressure, and best spectacle-corrected Snellen Visual acuity. Results: Twenty-four subjects were enrolled and all subjects completed 6 months follow-up. At the 1-month follow-up, TearCare subjects demonstrated an improvement from baseline in mean (±SD) TBUT of 11.7±2.6 seconds compared with an average worsening of -0.3±1.1 seconds for subjects in the WC group (p,0.0001). Significantly greater improvements in the change from baseline in meibomian gland scores, as well as corneal and conjunctival staining scores, were observed in the TearCare group. Subjects in the TearCare group also showed significantly greater improvement in dry eye symptoms as measured by the 3 questionnaires. Both treatments were well-tolerated. Conclusion: The findings of this pilot study suggest that the TearCare System is an effective treatment option for patients with DED, with the effects on the signs and symptoms of DED persisting for at least 6 months. [ABSTRACT FROM AUTHOR]

Background: Dry Eye Disease (DED) is a multifactorial disease, with a high prevalence, that can have a great impact on the quality of life of patients. The first step of treatment includes the use of lacrimal substitutes composed of polymers, possible to associate osmoprotectant agents to the lacrimal substitutes. The aim of this article is to analyze the properties of the combination of hyaluronic acid (HA), carmellose, and osmoprotectors (Optava Fusion®; Allergan, Inc., Irvine, CA, USA) on DED. General considerations on the use of artificial tears are also proposed. Methods: A group of ophthalmologists, experts in the management of the ocular surface, analyzed different aspects related to DED; among them, the use of artificial tears in general and the properties of the combination of HA, carmellose, and osmoprotectors, in particular, were discussed. A review of the literature was carried out, which included different articles published in Spanish, English, and French until April 2017. Conclusions: DED is a common chronic pathology that usually requires sustained treatment. In addition, the combination of HA, carmellose, and osmoprotectors has proven to be effective in the treatment of symptoms and signs of dry eye by the synergistic action of all its components. This review provides key elements to help ophthalmologists who begin in the management of DED. [ABSTRACT FROM AUTHOR]

Purpose: The objective of this study was to report the evaluation of efficacy and safety of cyclosporine A cationic emulsion (CsA CE) 0.1% for the treatment of severe keratitis in adults with dry eye disease (DED) in a French early-access program. Methods: Patients with DED and severe keratitis (corneal fluorescein staining [CFS] score of 3-5 on the Oxford scale and/or the presence of corneal lesions [filaments or ulcers]) were enrolled in a compassionate use program (Authorization for Temporary Use [ATU]) for oncedaily CsA CE, which was approved by French health authorities prior to its registration. Efficacy and safety at 1, 3, 6, and 12-month follow-up visits were evaluated. Results: The ATU cohort (n=1,212; mean age =60.5 years; 79.5% female; 98.1% with severe keratitis; 74.5% with corneal lesions) consisted of 601 CsA-naïve patients and 611 patients treated previously with other CsA formulations. The primary DED etiology was Sjögren's syndrome (48.7%). Clinical benefit could be discerned among 548 evaluable patients from months 1 to 12: keratitis improvement, 44.8% at month 1 and 42.1% at month 12; keratitis stabilization, 47.2% and 45.7%, respectively; symptom improvement, 47.2% and 48.6%; and symptom stabilization, 44.8% and 45.0%. Corneal clearing (CFS score =0) increased from 4.8% (month 1) to 11.4% (month 12). No unexpected safety concerns were identified; instillation site pain (10.2%) and eye irritation (7.8%) were the most common adverse events. Conclusion: The French ATU cohort provides supportive data on the clinical benefit of CsA CE in improving/stabilizing symptoms and corneal damage in DED patients with severe keratitis in real-world clinical practice. [ABSTRACT FROM AUTHOR]

Purpose: To compare the in vivo precision of two commercially available point-of-care osmometers among normal subjects with no dry eye disease. Methods: Twenty healthy adults with healthy ocular surfaces were evaluated by licensed eye care practitioners. All subjects had low Ocular Surface Disease Index score (,5), normal tear breakup time (.10 seconds), and no evidence of corneal fluorescein staining. Five consecutive measurements of tear osmolarity were measured on each eye using each of the two osmometers: the TearLab Osmolarity System (TearLab) and the I-Med i-Pen (i-Pen), for a total of 200 measurements per device. Performance of the osmometers was determined by specificity, estimated by the percentage of osmolarity data at or below the clinical cutoff (308 mOsm/L) and precision, and represented by the standard deviation per subject. In addition, to assess analytical performance, on each day of patient testing, standardized osmolarity quality control solutions (338 mOsm/L) were tested on the TearLab per manufacturer instructions. i-Pen manufacturer instructions do not neither provide for, nor recommend quality control procedures. Results: The mean age of the 20 subjects was 27±8 years (range: 19-48 years, 16 females, four males). Over 2 months of testing, the TearLab reported analytical performance on quality control solutions of 335.8±4.2 mOsm/L with a coefficient of variation of 1.3%. In the subject cohort, 90.9% of TearLab measurements were in the normal range #308 mOsm/L. The i-Pen reported 37.5% of all measurements in the normal range. The average intra-subject osmolarity of the TearLab was 295.4±8.6 mOsm/L, which was significantly lower and less variable than the i-Pen, which reported an average of 319.4±20.3 mOsm/L (P,0.001). When the measurements were grouped by subject, the TearLab accurately identified 100% of subjects as normal while the i-Pen accurately identified only 15% of subjects as normal. Conclusion: In this randomized comparative study of two point-of-care osmometers among normal, healthy non-dry eye subjects, the TearLab Osmolarity System demonstrated accuracy, precision, and agreement with clinical interpretation in line with the manufacturer claims. The i-Pen lacked sufficient performance to delineate subjects with and without dry eye disease. [ABSTRACT FROM AUTHOR]

Selective laser trabeculoplasty is a laser treatment to treat glaucoma. It was initially indicated for open-angle glaucoma but has been proven to be efficacious for various types of glaucoma. This review article summarizes the few rare complications that can be seen with selective laser trabeculoplasty. It also makes recommendations on how to avoid these problems and how to treat patients when these rare complications arise. [ABSTRACT FROM AUTHOR]

Background: To investigate the effects of selective laser trabeculoplasty (SLT) on macular thickness change. Methods: Forty eyes of 40 consecutive patients with uncontrolled primary open-angle glaucoma with medical treatment were included in this prospective study. SLT was performed to the inferior 180°, and macular thickness was measured. Data were collected before SLT, and 1 week and 1 month after SLT. Macular thickness evaluation was performed in five quadrants, the central 1 mm quadrant (fovea = F), the nasal 3 mm quadrant surrounding F (NQ), temporal quadrant, superior quadrant (SQ), and inferior quadrant (IQ). The preoperative and postoperative thicknesses were compared. Results: There was an increase in macular thickness in the NQ, IQ, and SQ on the first week after SLT compared to preoperative measurements. On the other hand, there was no significant increase in the F and temporal quadrant. On the first month after SLT, thickness in the NQ, IQ, and SQ was back to preoperative measurements, and there was no significant change between the preoperative measurements in any quadrant. Conclusion: There was no significant increase in macular thickness shortly after SLT in our study. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the evidence in the peer-reviewed literature regarding the use of tear osmolarity as a physiological marker to diagnose, grade severity, and track therapeutic response in dry eye disease (DED). In addition, to review the evidence for the role of tear osmolarity in the pathophysiology of DED and ocular surface disease. Methods: A literature review of all publications after the year 2000, which included the keywords "tear osmolarity", was conducted. Relevant articles were graded according to quality of evidence and research, using the University of Michigan Practice Guideline and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) rating systems. Articles were further categorized by the nature of any reported financial support and by the overall impression they provided related to tear osmolarity. Results: A total of 164 articles were identified as relevant to the search criteria, although some were editorials, and some were written in a foreign language. Of the total, it was possible to grade 159, and an overall impression was generated for 163. A positive impression of tear osmolarity in DED diagnosis was evident in 72% (117/163) of all articles, with a neutral impression in a further 21% (35/163); 7% had a negative impression. The percentage of positive impressions appeared independent of the quality of research; 73% (38/52) of articles graded high/moderate quality supported the use of tear film osmolarity measurement in DED diagnosis. Impressions were also independent of the source of financial support, with 72% (75/104) of independent studies positive. Conclusion: The literature broadly supports the use of tear film osmolarity as an objective numerical measure for diagnosing, grading severity, and managing treatment of DED. [ABSTRACT FROM AUTHOR]

Purpose: The accurate diagnosis and classification of dry eye disease (DED) is challenging owing to wide variations in symptoms and lack of a single reliable clinical assessment. In addition, changes and severity of clinical signs often do not correspond to patient-reported symptoms. To better understand the inconsistencies observed between signs and symptoms, we conducted a systematic literature review to evaluate published studies reporting associations between patient-reported symptoms and clinical signs of DED. Methods: PubMed and Embase were searched for English-language articles on the association between clinical signs and symptoms of DED up to February 2014 (no lower limit was set). Results: Thirty-four articles were identified that assessed associations between signs and symptoms, among which 33 unique studies were reported. These included 175 individual sign- symptom association analyses. Statistical significance was reported for associations between sign and symptom measures in 21 of 33 (64%) studies, but for only 42 of 175 (24%) individual analyses. Of 175 individual analyses, 148 reported correlation coefficients, of which the majority (129/148; 87%) were between -0.4 and 0.4, indicating low-to-moderate correlation. Of all individual analyses that demonstrated a statistically significant association, one-half (56%) of reported correlation coefficients were in this range. No clear trends were observed in relation to the strength of associations relative to study size, statistical methods, or study region, although results from three studies did suggest that disease severity may be a factor. Conclusion: Associations between DED signs and symptoms are low and inconsistent, which may have implications for monitoring the response to treatment, both in the clinic and in clinical trials. Further studies to increase understanding of the etiopathogenesis of DED and to identify the most reliable and relevant measures of disease are needed to enhance clinical assessment of DED and the measurement of response to therapeutic interventions. [ABSTRACT FROM AUTHOR]