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Background: Dry eye disease is one of the most common disorders we see in practice today. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO®) (©Bausch + Lomb) is a novel, non-aqueous, single entity, preservative-free ophthalmic drop recently approved by the FDA for treatment of the signs and symptoms of dry eye disease. Purpose: While the safety and efficacy of PFHO has been demonstrated in non-contact lens wearers, its safety and potential benefits in habitual contact lens wearers have not been explored. This report presents the results of a trial designed to evaluate the safety of PFHO and its effect on contact lens comfort, specifically in established contact lens wearers. Patients and methods: The study included 47 patients who were adjusted contact lens wearers with a best corrected visual acuity of 20/25 or better at distance. All the patients were healthy contact lens wearers with no dry eye symptoms. Results: A significant improvement in comfort scoring was observed without any significant changes in osmolarity, meibography scores, and total fluorescein staining. Conclusion: These findings suggest that PCHO is safe for contact lens wearers to use and shows promise to reduce contact lens dropout. [ABSTRACT FROM AUTHOR]

Background: This research aims to investigate the influence of environmental factors on the treatment efficacy of ocular lubricants in patients from urban areas with dry eye disease (DED). Methods: A phase IV clinical trial, which included 173 patients from major cities in Mexico, was randomly assigned to use ocular lubricants four times a day for 30 days. Ocular Surface Disease Index (OSDI), noninvasive tear film break-up time (NIBUT), ocular staining, and conjunctival hyperemia (CH) among other factors like weather, and air pollution as covariates were analysed. Results: After 30 days, OSDI score decreased by 14.8 points (p< 0.001), and NIBUT increased by 2.9 seconds (p< 0.001), with longer values observed in patients recruited in autumn and winter (additional 1.8 seconds, p< 0.05) compared to those recruited in spring. Patients living in cities with cooler weather and high humidity, but low air quality had higher OSDI and conjunctival stain scores of up to 4.4 and 0.3 points, respectively, as compared to those living in cities with similar pollution and humidity levels but with higher temperatures (p-values= 0.019 and 0.050). Patients with moderate CH had an increase of up to 0.8 points in their corneal stain score (p< 0.010). We also found that ozone levels were related to the predicted changes in OSDI and NIBUT. Conclusion: This study demonstrated the impact of environmental factors on the signs and symptoms of DED and suggests that patients residing in cities with inadequately controlled air pollution can benefit from using ocular lubricants to alleviate their symptoms. Trial Registration: Trial is registered at clinicaltrials.gov (NCT04702776). [ABSTRACT FROM AUTHOR]

Purpose: To assess changes in symptoms and ocular surface signs following a bilateral sutureless treatment of dehydrated amniotic membrane (dAM) under a specialised bandage contact lens (sBCL) in patients with moderate-to-severe dry eye disease (DED). Patients and Methods: In this prospective pre-post interventional study, 35 patients diagnosed with moderate-to-severe DED, with an Ocular Surface Disease Index (OSDI) score > 30 on current treatment, were enrolled. Assessments were conducted at baseline (day − 30), after 30 days run-in with no additional treatment (day 0 – control), and 30 days post sBCL+dAM treatment (day 30 – treatment). Intervention involved two successive bilateral 4-5 day sutureless applications of dAM (17mm diameter, with a 6 mm central aperture, Omnigen® VIEW) under an 18mm sBCL (OmniLenz®). Symptomatology and ocular signs were measured using OSDI, Dry Eye Questionnaire-5 (DEQ-5), Symptom Assessment iN Dry Eye (SANDE), and other ocular surface health indicators including non-invasive breakup time, corneal and conjunctival staining, and lid wiper epitheliopathy length and width (LWE). Results: While symptomatology remained stable during the 30-day no-treatment run-in, 1-month post-dAM treatment, there was a significant reduction in OSDI scores (from 55.8 to 32.3, p< 0.001), DEQ-5 (from 14.6 to 10.0, p< 0.001), SANDE frequency (from 65.2 to 43.6, p< 0.001), and SANDE severity (from 59.8 to 41.1, p< 0.001). Additionally, there was a notable decrease in the width of LWE staining, from grade 2 (50– 75% of the lid wiper) to grade 1 (25– 50% of the lid wiper) (p=0.011). Conclusion: A bilateral 8– 10-day treatment duration with dAM applied with sBCL demonstrated a 31 to 42% improvement in symptomatology and a decrease in ocular surface signs of mechanical stress. This innovative bilateral treatment approach offers a promising treatment modality for patients with refractory moderate-to-severe DED. [ABSTRACT FROM AUTHOR]

aime E Dickerson Jr9,101Private Practice, Philadelphia, PA, USA; 2Schwartz Laser Eye Center, Scottsdale, AZ, USA; 3Loh Ophthalmology Associates, Miami, FL, USA; 4Cleveland Eye Clinic, Brecksville, OH, USA; 5Rosenberg School of Optometry, University of the Incarnate Word, San Antonio, TX, USA; 6LASIK San Antonio, Kerrville, TX, USA; 7Gordon Schanzlin New Vision Institute, La Jolla, CA, USA; 8Kannarr Eye Care, Pittsburg, KS, USA; 9Sight Sciences, Menlo Park, CA, USA; 10North Texas Eye Research Institute, University of North Texas Health Science Center, Fort Worth, TX, USA Correspondence: Jaime E Dickerson Jr, Email [email protected] Purpose: To evaluate dry eye disease (DED) signs and symptoms six months after a single treatment with Localized Heat Therapy (LHT) (TearCare, Sight Sciences) for patients previously treated for six months with cyclosporine (0.05%) ophthalmic emulsion (CsA) BID (Restasis, Allergan). Setting: Nineteen ophthalmic and optometric practices in 11 US states. Design: Multicenter, cross-over, six month extension to the SAHARA randomized, controlled trial (RCT). Included patients were those randomized to CsA in Phase 1 of the SAHARA RCT. Methods: This was the second phase of the SAHARA RCT in which, following the 6-month endpoint, all patients that had been randomized to CsA discontinued CsA and were treated with LHT and subsequently followed for an additional six months. Outcome measures at 12 months for CsA patients crossed over to LHT included TBUT, OSDI and MGSS. Results: One hundred and sixty-one patients (322 eyes) were analyzed. Mean (SD) baseline TBUT prior to CsA was 4.4 (1.2) seconds, 5.6 (2.6) at 6 months which improved to 6.6 (3.2) and 6.1 (2.8) seconds (both P < 0.001) at 9 and 12 months (3, 6 months post LHT). Mean (SD) OSDI was 50.0 (14.9) at baseline and 34.2 (21.5) after CsA. With LHT at 6 months, this improved to 30.0 (20.6) and 31.0 (19.5) at 9 and 12 months (P = 0.162 vs month 6, P < 0.0001 vs baseline). MGSS was 7.1 (3.2) at baseline, 13.3 (8.2) at the end of CsA treatment which improved to 17.4 (8.8) and 16.1 (9.0) at 9 and 12 months; both P < 0.001. Conclusion: SAHARA showed 6-month superiority of LHT to CsA in clinical signs and non-inferiority in symptom scores. This extension shows that patients treated with CsA for 6 months can achieve meaningful additional improvement in signs and symptoms lasting for as long as 6 months following a single LHT treatment without the need for topical prescription therapy. [ABSTRACT FROM AUTHOR]

Objective measurements of OSDI and osmolarity were the most consistent between sites. A large proportion of subjects exhibited high symptoms and hyperosmolarity but no other obvious signs of dry eye disease, most of whom were undiagnosed by clinical assessment without access to the osmolarity measurement. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to compare the efficacy of using a combination of antibiotic and corticosteroid eye drops to using the same combination in addition to sodium hyaluronate eye drops. Patients and Methods: This study included patients who underwent phacoemulsification for age-related cataract and presented to the ophthalmology department or outpatient clinic of the two hospitals in the study with DED during the period from January 2020 to January 2023. The study involved a two-pronged approach in which we retrospectively analyzed the prospectively maintained data of the patients and prospectively called the patients for an evaluation of the dry eye impact on vision-related function. The study patients were recruited from two hospitals. During the study period, patients who were treated with a combination of antibiotic and corticosteroid eye drops were enrolled in Group A, and those who were treated with the same combination with sodium hyaluronate eye drops were enrolled in Group B. Results: The present study included 143 patients with post-phacoemulsification DED. Group A included 70 patients, and Group B included 73 patients. There was statistically significant improvement 4 weeks after treatment (p < 0.05) in the two groups. Comparing the two groups showed statistically significant improvements in group B compared to group A (p < 0.05). Assessment of the overall efficacy outcome revealed a statistically significant high percentage of cure (35.6% vs 1.4%) and high effectiveness (42.5% vs 13.6%) and a low percentage of effectiveness (21.9% vs 74.3%) and ineffectiveness (0.0% vs 5.7%) in Group B compared to Group A (p < 0.001). Conclusion: Combining sodium hyaluronate eye drops with tobramycin and dexamethasone eye drops yielded obviously better efficacy outcomes compared to using tobramycin and dexamethasone eye drops alone. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a chronic ocular surface disorder often characterized by decreased tear production and rapid tear evaporation that affect tear film stability and homeostasis. The common symptoms of DED include ocular discomfort, visual disturbances, dryness, and itching. Artificial tears are the mainstay of DED management and supplement one or more layers of the tear film. Artificial tear drops are available as a combination of viscosity-enhancing agents (demulcents/lubricants), humectants, and buffers either with or without preservatives. Artificial tears, as a combination of components (polymers/demulcents/viscosity-enhancing agents), can provide synergistic action compared with a single component for the management of multifactorial signs and symptoms of DED. This review describes the formulation components, physicochemical properties, mechanism of action, and summary of preclinical and clinical evidence on the hydroxypropyl guar-hyaluronic acid (HPG-HA) dual-polymer lubricant eye drops (SYSTANE™ HYDRATION). The dual-polymer eye drops consist of dual demulcents (propylene glycol and polyethylene glycol 400) and the polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA). When instilled on the ocular surface, HPG forms a cross-linked gel matrix with borate ions that prolongs the retention of demulcents, thus providing long-lasting lubrication and ocular surface protection. Additionally, HA stabilizes the tear film, increases corneal wettability, and reduces friction during blinks due to its hygroscopic and viscoelastic properties. Preclinical evidence demonstrates that HPG HA dual-polymer lubricant eye drops provide protection against desiccation by cell hydration and surface retention, cell barrier protection, prolonged lubrication, and promotion of corneal re-epithelialization. Clinical scientific evidence demonstrates that HPG HA dual-polymer lubricant eye drops are safe and effective in the management of DED. Specifically, they reduce the signs and symptoms of DED, reduce dry eye symptoms post-cataract surgery, and improve tear film quality in healthy eyes. [ABSTRACT FROM AUTHOR]

Purpose: A randomized clinical trial was run to evaluate the effectiveness of a preservative-free 0.4% sodium hyaluronate eye drop (LOF) in different dosage schemes to alleviate signs and symptoms of dry eye disease (DED).Methods: A total of 116 subjects with mild-to-moderate DED were included, and 111 completed the study (from which 67.6% were female and 65.3% were users of oral contraceptives). Patients were randomly assigned to instill a drop of LOF either 2 (BID), 4 (QID) or 6 (6TD) times a day (at least 3 hours apart) for 30 days. The clinical parameters and symptom endpoints were Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), ocular surface staining, and conjunctival hyperemia. Other parameters evaluated were chemosis, best corrected visual acuity, and the incidence of adverse events (AE).Results: There was a significant reduction in OSDI scores by day 30 in all groups. The recovery of the OSDI score back to normal values was observed in 51.4% of patients treated (50%, 48.6%, and 55.6% in BID, QID, and 6TD, respectively, p = 0.822). Similar improvement was observed for TBUT, 50.5% of patients increased this variable to > 10 seconds (39.5%, 51.4%, and 61.1%, p = 0.175), and for ocular surface staining, ≥ 72% showed Grade 0. There were no significant differences among posology groups regarding ocular surface staining, conjunctival hyperemia, or any safety parameters. No overall improvement in OSDI and TBUT to normal values was noted for 31 patients (21 were female and 71.4% users of contraceptive drugs).Conclusion: The ophthalmic use of preservative free LOF, 2, 4 or 6 times a day, may alleviate clinical parameters and symptoms in 50% of patients with mild-to-moderate DED after a one-month treatment. This improvement seemed to be less ubiquitous in patients within reproductive age and using oral contraceptives.Trial Registration: This trial is registered at clinicaltrials.gov (NCT0704531). [ABSTRACT FROM AUTHOR]

aimi,5 Yahya Al-Najmi61Ophthalmology Department, King Faisal Medical Complex, Taif, Saudi Arabia; 2Ophthalmology Department, Alhada Military Hospital, Taif, Saudi Arabia; 3Ophthalmology Department, Jeddah Eye Hospital, Jeddah, Saudi Arabia; 4Ophthalmology Department, Asir Central hospital, Abha, Saudi Arabia; 5Ophthalmology Department, College of Medicine, Majmaah University, Majmaah, Saudi Arabia; 6Ophthalmology Department, Saggaf Eye Center, Jeddah, Saudi ArabiaCorrespondence: Yahya Al-Najmi, Ophthalmology Department, Saggaf Eye Center, Abdullah Salman St., Al Faiha'a Dist., P.O. Box: 31903, Jeddah, 21418, Saudi Arabia, Tel +966 564844281, Email [email protected] Purpose: To estimate the prevalence and determinants of Ocular Surface Disease Index (OSDI) score based dry eye disease (DED) among the adult urban population of four cities located at high altitudes in Southwest Saudi Arabia.Methods: This cross-sectional survey was held in 2023. OSDI questionnaire was used to collect the responses of the adult participants. The score was further graded into none, mild, moderate, and severe DED to estimate age-sex-adjusted DED prevalence. The OSDI score was correlated to demographic (age group, gender, education, occupation, city) and risk factors like smoking and co-morbidities.Results: Of the 401 adults, 388 (response rate of 97.8%) participated. The age-sex-adjusted prevalence of mild, moderate, and severe DED was 21.7%, 13.1%, and 32%, respectively. The median ODSI score was 22.9 [Interquartile range (IQR) 10.4; 47.9)]. The score was significantly higher in females (Mann–Whitney U-test P = 0.038), residents of Taif city (KW P = 0.05), those with primary/middle school education (Kruskal–Wallis P = 0.004), comorbidities like hypertension, asthma (KW P < 0.001) and risk factors like past refractive surgeries, arthritis (KW P = 0.013). Education status (P < 0.001) [B = − 9.0 95%] and presence of comorbidity (P = 0.022), [B = − 0.823] were significant predictors of DED.Conclusion: The prevalence of DED and severe grade was high. The level of education and presence of comorbidities significantly influenced DED in the adult urban Saudi population of cities at high altitudes. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a common ocular condition, but the diagnosis relative to other ocular conditions and the evaluation of severity of the condition has often been difficult. This challenge can be due to clinical signs and symptoms not always correlating with each other. An understanding of the various components which create the condition, as well as the diagnostic measures used to evaluate these components, is useful to the clinician working with DED patients. This review paper will discuss traditional diagnostic options, diagnostic imaging, and Advanced Point of Care testing capabilities to determine the severity level of dry eye disease more adequately. [ABSTRACT FROM AUTHOR]

Purpose: To determine the effectiveness of subconjunctival application of a novel sirolimus liposomal formulation for the treatment of dry eye. Methods: A randomized, triple-blind, Phase II clinical trial. Thirty-eight eyes of 19 patients were included. Nine patients (18 eyes) assigned to the sham group (Sham) and 10 patients (20 eyes) to sirolimus-loaded liposomes group (Sirolimus). The treatment group received three doses of subconjunctival liposome-encapsulated sirolimus and the sham group received three doses of liposomal suspension without sirolimus. Subjective (Ocular Surface Disease Index, OSDI) and measured (corrected distance visual acuity, conjunctival hyperemia, tear osmolarity, Schirmer's test, corneal/conjunctival staining and matrix metalloproteinase-9) variables were measured. Results: Sirolimus-entrapped liposomes-treated group OSDI scores changed from 62.19 (± 6.07) to 37.8 (± 17.81) (p=0.0024), and conjunctival hyperemia from 2.0 (± 0.68) to 0.83 (± 0.61) (p< 0.0001); Sham group with OSDI scores from 60.02 (± 14.2) to 36.02 (± 20.70) (p=0.01), and conjunctival hyperemia from 1.33 (± 0.68) to 0.94 (± 0.87) (p=0.048). All the other evaluated outcomes only showed significant differences in the sirolimus group: corneal/conjunctival staining score (p=0.0015), lipid layer interferometry (p=0.006), and inferior meibomian gland dropout (p=0.038). No local or systemic adverse effects regarding the medication itself were reported, and the administration route was well accepted. Conclusion: Our findings suggest that sub-conjunctival sirolimus-loaded liposomes are effective in reducing both signs and symptoms of dry eye in patients with poorly controlled moderate-to-severe DED, while avoiding other topical administration adverse effects. Further investigation with a larger sample size is required to determine long-term effects. [ABSTRACT FROM AUTHOR]

Purpose: To determine the prevalence of dry eye disease (DED) in patients scheduled for cataract surgery in a Norwegian eye clinic. Patients and Methods: 218 patients scheduled for cataract surgery were examined for DED in one randomly selected eye and questioned regarding symptoms and risk factors. Patients were diagnosed with DED if they fulfilled the DEWS II criteria with symptom score > 12/100 with Ocular Surface Disease Index (OSDI) questionnaire, and the presence of any of the three signs: tear osmolarity > 307 mOsm/L in either eye or a difference in osmolarity between the two eyes of > 8 mOsm/L, corneal fluorescein staining (CSF) ≥ grade 2 and non-invasive tear film breakup time (NIKBUT) of < 10 seconds. Additional tests were the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear meniscus height (TMH), Schirmer 1, tear film thickness (TFT), corneal sensitivity and meibography (meiboscore). Dry eye test outcomes were correlated with risk factors for DED. Results: The prevalence of DED was 55.5% according to the DEWS II criteria. The abnormal osmolarity percentage was 66.5, while 29.8% had shortened NIKBUT and 19.7% exhibited CFS ≥ 2. 57% had Schirmer 1 ≤ 10 mm/5 min, and 81.1% had a meiboscore of ≥ 1. 71.2% of subjects scored positive for DED symptoms using the OSDI questionnaire and 69.3% using SPEED. Logistic regression analysis showed that higher age correlated with a lower OSDI symptom score, reduced corneal sensitivity and increased meibomian gland atrophy. Female sex was associated with higher odds of having DED, abnormal NIKBUT and abnormal CFS. Ocular tests for DED did not correlate with OSDI symptom scores when assessed with Spearman's rank analysis. Conclusion: The prevalence of DED in an elderly Norwegian population scheduled for cataract surgery is high and associated with female sex. There was a lack of correlation between signs and symptoms of DED. [ABSTRACT FROM AUTHOR]

Purpose: We evaluate the treatment effect of OC-01 (varenicline solution) nasal spray (VNS) in dry eye disease (DED) subjects from two randomized trials who self-reported autoimmune disease (AID). Patients and Methods: Post hoc subgroup analysis of subjects reporting a history of AID from the integrated OC-01 VNS 0.03 or 0.06 mg and vehicle control (VC) treatment groups of the ONSET-1 and ONSET-2 trials. Mean change in Schirmer test with anesthesia score (STS, mm) and Eye Dryness Score (EDS) from baseline to 28 days was compared between OC-01 VNS and VC groups. Consistency of treatment effect in subjects with and without AID was evaluated using treatment–subgroup interaction terms in ANCOVA models for mean changes from baseline STS and EDS, and in a logistic regression model for proportion achieving ≥ 10 mm STS improvement. Results: Of the 891 participants, 31 reported comorbid AID. In all models, the treatment–subgroup interaction terms were not significant (p> 0.05), indicating consistency of therapeutic effect of OC-01 VNS in subjects with and without AID. In subjects with AID, the treatment difference for STS was 11.8 mm and − 9.3 for EDS and difference for proportion of subjects with ≥ 10 mm STS improvement was 61.1%. The most common adverse event was sneeze (82– 84%), graded as mild by 98% of subjects. Conclusion: OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further support use of OC-01 VNS for DED in AID patients. [ABSTRACT FROM AUTHOR]

Purpose: Validation of the novel Lexitas modified NEI scale for use in assessment of corneal fluorescein staining. Patients and Methods: A series of 18 illustrations and 14 clinical photographs depicting varying severity levels of corneal fluorescein staining were assessed by 3 independent examiners. Regions of the cornea were graded for staining severity based on 3 different grading scales: the original NEI staining scale (density-based scoring; 0– 3 scale), a structured version of the NEI scale (dot-count scoring; 0– 3 scale), and the Lexitas modified NEI staining scale (0– 4 scale with half-point increments). Kappa statistics (simple and weighted) were computed to determine intra-examiner image grading repeatability for each examiner over 2 separate assessments. Inter-examiner assessment reliability utilized the scores from the first read of each examiner, and pairs of examiners to compute kappa statistics. Results: Data was analyzed from the scores provided by the examiners from each gradable corneal region on 32 images (18 illustrations and 14 photographs) for a total of 154 corneal regions across the 3 grading scales for each validation run. The mean intra-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.67/0.72, 0.91/0.94, 0.80/0.92 for the graded illustrations, and 0.83/0.88, 0.76/0.85, 0.77/0.88 for the graded photographs, respectively. The mean inter-examiner simple/weighted kappa values using the NEI density, NEI dot count, and the Lexitas modified NEI staining scales were 0.59/0.65, 0.86/0.90, and 0.78/0.91 for the graded illustrations, and 0.80/0.88, 0.84/0.89, 0.69/0.88 for the graded photographs, respectively. Conclusion: The expanded scale of the Lexitas modified NEI staining scale demonstrated a high degree of reliability and repeatability of grading assessments within and across individual examiners, comparing favorably with the original NEI staining scale. A future investigation into the in-office utility of the Lexitas modified NEI staining scale is warranted. [ABSTRACT FROM AUTHOR]

Purpose: Students spend extended hours using electronic devices due to online teaching. Digital eye strain (DES) and dry eye disease (DED) symptoms are both associated with prolonged screen exposure time and may co-occur. This study aimed to evaluate the correlation between DES and DED symptoms and determine the prevalence of DED according to the severity of DES. Patients and Methods: This cross-sectional study was conducted among international students in Chinese universities. The survey was built using Wenjuan Mini Program and distributed using the WeChat platform. The questionnaire assessed participants' screen exposure, the 20-20-20 rule, ED practices, and DED awareness. Computer Vision Syndrome Questionnaire (CVS-Q) and Dry Eye Questionnaire (DEQ-5) were used to diagnose DES and DED symptoms, respectively. Results: 498 students completed the survey, but 452 were considered for the study. Predictors of DES and DED symptoms were conjunctivitis, eye allergy, glares, tired eye, neck pain, back pain, PhD students, and daily spending > 9h on screen (P < 0.05 for all). We observed that an increase in DES scores also exponentially increases DED scores. Among students diagnosed with DES symptoms, 26.5% had mild to moderate DED symptoms, and 8.2% had severe DED symptoms. In contrast, only 8.4% and 0.9% of those with asymptomatic DES had mild to moderate and severe DED symptoms, respectively (P < 0.000). A strong and significant positive correlation (r = 0.695, P < 0.000) between DES and DED scores was found. Conclusion: We found an extremely high prevalence of DES and DED symptoms compared to the previous studies with a similar population group. We believe that the prevalence of DED may be underestimated in the young population. Training about proper ED practices is mandatory to prevent these deleterious ocular surface conditions. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the efficacy, safety and tolerability of topical omega-3 polyunsaturated fatty acids (PUFA) as an innovative treatment of dry eye disease (DED). Patients and Methods: In a pilot, multicenter, masked-observer, randomized, active-controlled, non-inferiority study in Germany, patients self-treated their eyes with daily instillations of eye drops containing either omega-3 PUFA or povidone as major components for three months. At four and twelve weeks, efficacy was among others evaluated based on Ocular Surface Disease Index (OSDI), ocular surface symptoms intensity, general clinical impression, tear break-up time (TBUT), corneal fluorescein staining using the Oxford grading scale, tear volume, and matrix metalloproteinase-9 (MMP-9) concentration in the tear film. Safety evaluation included visual acuity, intraocular pressure, and the incidence of adverse events. Co-primary endpoints were the mean percent changes from baseline of TBUT and OSDI after four weeks. Results: In total 80 patients were included, of whom 37 in the PUFA group and 39 in the povidone group were evaluable for the co-primary endpoints. Patients had a mean age of 52 years and > 80% were women. Both co-primary endpoints (TBUT and OSDI) significantly improved from baseline in both treatment groups, at Week 4 and Week 12 and the statistical analysis demonstrated topical omega-3 PUFA to be non-inferior to 2% povidone for these two parameters. Both treatments resulted in a significant improvement of most secondary efficacy endpoints as well, often with a slight difference in favor of PUFA, not reaching statistical significance though. One non-severe, treatment-related local AE was reported in each group. Conclusion: Omega-3 PUFA-based eye drops proved to be non-inferior to povidone-containing eye drops in the treatment of signs and symptoms of dry eye. This treatment may thus be an additional tool for the management of DED. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a multifactorial disease of the ocular surface that may be accompanied by discomfort and visual disturbances to a level that reduces quality of life. Artificial tears are a common first-line therapy for DED that aim to supplement the tear film but do not address the underlying causes of DED. Because of the complexity and variability of the disease, personalized treatment beyond artificial tears is important for successful management. This review describes artificial tears and the current knowledge in the personalized approach to the management of DED. There is evidence that artificial tears can reduce symptoms and signs of DED; however, a proportion of patients have been found to show limited or no improvement with artificial tears. Furthermore, the effectiveness of artificial tears may depend on patient compliance and type of artificial tear product used. Personalized management of DED with other treatments involves identifying features of the disease, including the subtype of DED, the presence of inflammation, and the coexistence of external and behavioral contributing factors. Various measures exist to characterize DED, including assessments of the tear film lipid layer, the meibomian glands, tear volume, tear osmolarity, and matrix metalloproteinase 9 levels. Because individuals can show variable features, the most prominent clinical findings, comorbidities, triggering events, and treatment history should be considered to determine the best treatment choices for patients. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate OC-01 [varenicline solution nasal spray (VNS)] tear production and symptom outcomes in patients with dry eye disease by age, gender, race, ethnicity, and artificial tear use status. Patients and Methods: Adults ≥ 22 years of age diagnosed with dry eye disease, with Ocular Surface Disease Index score ≥ 23, corneal fluorescein staining score ≥ 2 in ≥ 1 region or ≥ 4 for all regions, and baseline Schirmer Test Score (STS) ≤ 10 mm, with no restrictions on eye dryness score (EDS). Efficacy was assessed using integrated data from ONSET-1 and ONSET-2 [vehicle control (VC), n=294; OC-01 VNS 0.03 mg, n=308]. Subgroups included age (≤ 55, 56− 65, > 65 years), gender (male, female), race (White, Black or African American), ethnicity (Hispanic or Latino, Not Hispanic or Latino), and artificial tear use (yes, no). Analysis of covariance models, with the covariates treatment, study site, and baseline severity measures, were used to calculate treatment−VC differences. Consistency of effect among subgroups was evaluated by conducting interaction tests. Results: Consistency of treatment effect across subgroups was observed for all endpoints, with P value for all treatment−subgroup interaction terms > 0.05. For % of patients with ≥ 10mm improvement in STS and least squares (LS) mean change from baseline in STS and EDS, there was improvement in tear production across demographic group categories. Artificial tear use did not change STS or EDS outcomes with OC-01 VNS. Conclusion: OC-01 VNS improved tear production and patient-reported symptom outcomes across a broad range of patients by age, gender, race, and ethnicity, and regardless of artificial tear use status at baseline. OC-01 VNS demonstrated a consistent benefit across an extensive range of patients with dry eye disease. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effects of autologous platelet‐rich plasma (PRP) drops for evaporative dry eye (EDE) disease from meibomian gland dysfunction (MGD). Methods: This is a retrospective, consecutive case series of 20 eyes of 10 patients with EDE from MGD treated with PRP drops from November 2020 to November 2021 at a single outpatient clinic in Ontario, Canada. PRP drops were prepared from whole blood using a two-step centrifugation method. Patients were instructed to instill these drops six times daily for 4 weeks. The Canadian Dry Eye Assessment (CDEA) questionnaire score, patient subjective assessment (PSA) score, first and average non-invasive break-up times (f/a NIBUT), tear meniscus height (TMH), bulbar redness (BR), and meibograph grade (MG) were measured before and after the treatment course. Results: Significant improvements in dry eye symptoms and tear film parameters were observed. Dry eye symptoms significantly improved as per the CDEA (mean difference (MD) = − 5.45, 95% confidence interval (CI) = [− 7.9, − 3.1], p< 0.001) and PSA (MD = − 2.6, 95% CI = [− 3.9, − 1.2], p< 0.001). There were significant improvements in tear film parameters including fNIBUT (MD = 3.85s, 95% CI = [1.2, 6.8], p=0.006), aNIBUT (MD = − 6.81s, 95% CI = [5.7, 11.1], p< 0.001) and TMH (MD = 0.08, 95% CI = [0.003, 0.2], p=0.045). There was an improvement in conjunctival injection as measured by BR (MD = − 0.36, 95% CI = [− 0.4, − 0.15], p=0.373). Five eyes experienced a one-grade improvement in MG (p=0.453), and none experienced worsening in MG with treatment. No temporary or permanent adverse effects were noted. Conclusion: Four weeks of PRP therapy resulted in significant functional improvements in dry eye symptoms and tear film quality and quantity. Improvements in conjunctival injection and microstructural improvements in meibomian glands were also observed in some eyes. Overall, PRP is a promising treatment option for patients with EDE from MGD refractory to conventional treatments. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) has a higher prevalence than many important systemic disorders like cardiovascular disease and diabetes mellitus, representing a significant quality of life burden for the affected patients. It is a common reason for consultation in general eye clinics worldwide. Nowadays, the diagnostic and therapeutic approach at the high corneal and ocular surface specialty level should be reserved for cases of severe and chronic dry eye disease associated with systemic autoimmune diseases or complicated corneal and ocular surface pathologies. In such cases, the diagnostic and therapeutic approach is often complex, elaborate, time-consuming, and costly due to the use of extensive dry eye questionnaires, noninvasive electronic diagnostic equipment, and clinical laboratory and ancillary tests. However, other eye care specialists attend a fair amount of DED cases; therefore, its diagnosis, classification, and management should be simple, practical, achievable, and effective. Considering that many patients attending non-specialized dry eye clinics would benefit from better ophthalmological attention, we decided to elaborate a practical DED classification system based on disease severity to help clinicians discriminate cases needing referral to subspecialty clinics from those they could attend. Additionally, we propose a systematic management approach and general management considerations to improve patients' therapeutic outcomes according to disease severity. [ABSTRACT FROM AUTHOR]

Background: BroadBand light intense pulsed light (BBL-IPL) therapy has shown to reduce hordeolum and blepharitis frequency. This study aims to evaluate the efficacy and safety of BBL-IPL therapy in patients with dry eye disease (DED) from meibomian gland dysfunction (MGD). Methods: This is a retrospective, consecutive case series of 48 patients with DED from MGD who underwent BBL-IPL therapy from October 2016 to January 2019 at a single, outpatient clinic in Ontario, Canada. Clinical outcomes included first and average non-invasive keratograph tear break-up times (NIKBUT), bulbar redness (BR) scores, tear meniscus heights (TMH), visual acuity (VA) and meibograph grades. Patient-reported outcomes included the Canadian dry eye assessment (CDEA) questionnaire and patient subjective assessment (PSA) scores. Outcomes were measured at baseline and after completion of 4 monthly BBL-IPL sessions. Results: The mean severity of dry eye symptoms as measured by the CDEA and PSA decreased significantly from 19.78 ± 9.62 to 12.08 ± 7.40 (p< 0.001) and from 7.65 ± 1.74 to 4.77 ± 2.03 (p< 0.001), respectively. Twenty-five percent of patients reported no dry eye symptoms after treatment. The meibograph grade improved significantly in both eyes (p< 0.001). Approximately 71.0% and 80.1% of patients had an improved meibograph grade in the right and left eye, respectively. Near-significant improvements were observed for BR scores and VA. There was also a trend towards improved first/average NIKBUT and TMH scores. No adverse events were noted. Conclusion: BBL-IPL appears to be an effective and safe treatment modality in improving dry eye symptoms and meibomian gland function in patients with DED from MGD. [ABSTRACT FROM AUTHOR]

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]

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]

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]

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 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 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: 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]

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: 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: 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 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]