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Brian J Nguyen,1 Angela S Gupta,1 Jocelyn He,1,2 Gui-Shuang Ying,1,2 Vatinee Y Bunya,1 Ilaria Macchi,1 Mina Massaro-Giordano1 1Department of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA, USA; 2Department of Ophthalmology, Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Department of Ophthalmology, Scheie Eye Institute, University of Pennsylvania, 51 North 39th St, Philadelphia, PA, 19104, USA, Email mina@pennmedicine.upenn.eduPurpose: This study was to assess corneal epithelial thickness (CET) in patients with Sjogren’s disease (SjD).Methods: A retrospective chart review was conducted of SjD patients from September 2021 to January 2022. Patient demographics, unanesthetized Schirmer’s test, serologic markers, and symptoms as measured by the Ocular Surface Disease Index (OSDI) were reviewed. Epithelial thickness from both eyes was measured using anterior segment OCT at the central 3mm and concentric 5mm, 7mm, and 9mm zones for the superior, temporal, inferior, and nasal corneal quadrants. Associations between corneal epithelial thickness with patient demographics, clinical characteristics, and symptoms were evaluated using regression models.Results: Fifteen SjD patients (100% female) were included with a mean age of 58.4 years. Patients with Sjogren’s disease had a significantly thinner superior corneal epithelium compared to the inferior epithelium (mean 47.7mm vs 53.1mm, p = 0.001). The epithelial thickness mean standard deviation (MSD) was significantly inversely correlated with the unanesthetized Schirmer test (r=− 0.39, p = 0.005), suggesting that an overall variability of CET correlates with decreased aqueous tear production. SS-A, SS-B, ANA, and RF positivity were not associated with any measures of CET.Conclusion: This pilot study suggests that there is significant superior versus inferior thinning of corneal epithelium in Sjogren’s patients. There was a significant correlation between variability of corneal epithelial thickness and decreased tear production in Sjogren’s patients. Further larger studies are needed to understand the relationship of CET with objective and subjective measurements of ocular surface disease.Keywords: Sjogren’s disease, corneal epithelial thickness, anterior segment OCT

Jennifer B Nadelmann,1,2 Vatinee Y Bunya,1 Gui-Shuang Ying,3 Peiying Hua,3 Mina Massaro-Giordano1 1Department of Ophthalmology, Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 2Department of Ophthalmology, Weill Cornell Medicine, New York, NY, USA; 3Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Mina Massaro-Giordano, Department of Ophthalmology, Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, Tel +1-215-662-8100, Email mina@pennmedicine.upenn.eduPurpose: Platelet rich plasma (PRP) is an autologous preparation that concentrates platelets in a small volume of plasma. The purpose of this study was to determine if PRP eye drops improved the symptoms and signs of ocular surface disease.Patients and Methods: A retrospective case series was conducted of patients who were prescribed PRP eye drops. Subjects were excluded if they did not have follow-up, underwent intraocular surgery prior to follow-up, received nerve growth factor treatments, or did not have a baseline examination with photography. Symptoms were assessed using the Ocular Surface Disease Index (OSDI). Patients also underwent a slit lamp exam, ocular surface staining with fluorescein and lissamine green, and Schirmer testing.Results: The charts of 47 patients treated with PRP drops for ocular surface disease were reviewed. Sixty-four eyes of 32 patients were included in the study who had photographs of lissamine green staining taken at baseline and at follow-up. Thirteen patients (28%) had ocular graft-versus-host disease, 16 patients (34%) had Sjögren’s syndrome, and 4 patients (8.5%) had rheumatoid arthritis. There was a statistically significant decrease in OSDI score from baseline to follow-up (39.5 vs 30.8 points, p = 0.02). Among the 64 eyes included, 9 (14%) had an improvement in conjunctival lissamine green staining, while 6 (9%) had an increase in staining at follow-up. Among the 20 eyes with Schirmer testing, there was a borderline significant increase in score from baseline to follow-up (5.9 vs 9.7, p = 0.06). Among the 44 eyes that had corneal fluorescein staining (CFS) reported, 8 (18.2%) had decreased staining and 2 (4.5%) had increased staining at follow-up.Conclusion: Treatment with PRP drops was associated with a significant improvement in symptoms in patients with ocular surface disease. Future larger prospective studies are needed to further evaluate the efficacy of PRP drops for treating ocular surface disease.Keywords: ocular surface disease, cornea, lissamine green, Ocular Surface Disease Index, platelet-rich plasma

Zujaja Tauqeer,1 Stephanie E Jinno,1,2 Caroline W Chung,1 Mina Massaro-Giordano,1 Vatinee Y Bunya1 1Department of Ophthalmology, Scheie Eye Institute, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; 2Drexel University School of Medicine, Philadelphia, PA, USACorrespondence: Vatinee Y Bunya, Tel +1-215-662-8100, Email Vatinee.Bunya@pennmedicine.upenn.eduPurpose: Ocular adverse events have been reported in association with dupilumab, a monoclonal antibody to treat allergic diseases including atopic dermatitis (AD). We describe clinical findings and treatment of dupilumab-related ocular complications.Patients and Methods: Retrospective study of 19 dupilumab-treated AD patients seen for a new ocular complaint. Primary outcomes were specific ocular exam findings (conjunctival injection, corneal fluorescein staining, blepharitis, meibomian gland dysfunction (MGD)), treatments, and follow-up.Results: Nineteen dupilumab-treated AD patients were included. Median age was 47 years (range 18– 73). Over half were women (11/19) and majority were Caucasian (13/19). Symptom onset occurred at a mean of 99 days (range 23– 520 days) from first dupilumab dose. The most common symptoms were redness (63%), tearing (47%), and pruritus (37%). Most common ocular findings were conjunctival injection (75%) and corneal staining (60%). Blepharitis was seen in about a third (30%), and 25% had MGD. Initially, 10% were observed without treatment, while 15% were treated with artificial tears alone. Other treatments included antihistamine drops (20%) and steroid drops alone (15%). In 40% of patients, a combination of steroids and various other topical eye drops were prescribed. Eighty-four percent (16/19) of patients were seen for follow-up. Steroid drops were required at follow-up in 3 out of 4 patients initially treated with antihistamines alone and in two-thirds of patients initially treated with artificial tears only. Mean follow-up period was 88 days (range 5– 369). Dupilumab was discontinued in 31.5% (6/19) of patients; of those who discontinued, 3 restarted it later.Conclusion: Conjunctival injection was the most frequent dupilumab-related ocular symptom and most common exam finding followed by corneal staining. Most patients initially treated with antihistamine drops or artificial tears alone subsequently required steroid drops to control symptoms. Some patients who discontinued dupilumab restarted the medication after achieving adequate control of ocular symptoms.Keywords: dupilumab, atopic dermatitis, conjunctivitis, cornea, dry eye

Jonathan Lilley,1 Erin C O’Neil,1 Vatinee Y Bunya,1 Kennedy Johnson,1 Gui-Shuang Ying,2 Peiying Hua,2 Mina Massaro-Giordano1 1Department of Ophthalmology, Scheie Eye Institute, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; 2Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USACorrespondence: Mina Massaro-GiordanoDepartment of Ophthalmology, Scheie Eye Institute, Perelman School of Medicine at the University of Pennsylvania, 51 N. 39th Street, Philadelphia, PA, 19104, USATel +1 215-662-9393Email mina@pennmedicine.upenn.eduPurpose: To assess the efficacy and safety of an intranasal tear neurostimulator (ITN) device in Sjögren syndrome (SS) patients.Methods: This was a two-visit prospective, randomized, controlled, same-day crossover study in participants with SS. Inclusion criteria were assessed at a baseline screening visit and included an Ocular Surface Disease Index (OSDI) score ≥ 13, and a Schirmer with anesthesia ≤ 10 mm/5 min (in at least one eye), with a cotton swab stimulation induced increase of ≥ 4 mm in the same eye. Participants returned for the application visit, where they received intranasal and extranasal applications of the ITN in random sequence, separated by at least 60 min. Schirmer scores were measured in both eyes after each application and compared to baseline values. Generalized linear models were performed to compare the change in Schirmer scores from baseline, and generalized estimating equations were used to account for correlations from repeated measurements in the same eye and measurements from two eyes of the same patient.Results: Fifty-five participants were screened and 35 were enrolled (all female), ranging in age from 31 to 72 years (mean, 57 years). The baseline OSDI score ranged from 14 to 91 (mean, 50.5), and the baseline Schirmer score had a mean (SD) of 6.4 (3.5) ranging from 0 to 20 (mm/5min). Improvement in Schirmer scores was significantly greater for intranasal device application (13.5 mm/5min, 95% CI: 10.4, 16.5) compared to extranasal device application (0.8mm/5min, 95% CI: − 0.9, 2.4) (p< 0.0001). The effects of the intranasal device application were significant regardless of the participant’s baseline Schirmer score and systemic SS medication usage (p< 0.05).Conclusion: Intranasal application of the ITN device significantly increased tear production in a subset of SS patients compared to baseline and was more effective than extranasal application. While production of the ITN device was recently discontinued, our findings suggest that other therapies that neurostimulate the lacrimal function unit may be effective in a subset of SS patients.Keywords: Sjögren syndrome, intranasal tear neurostimulation, tear production

Purpose: To examine the ocular signs and symptoms in participants of the Sjögren's International Collaborative Clinical Alliance cohort, and to compare them across Sjögren's disease (SjD) status., Methods: Our study population comprised 3380 Sjögren's International Collaborative Clinical Alliance participants who had no missing data relevant to this study. Participants' SjD status was assessed using the updated 2016 American College of Rheumatism/European League Against Rheumatism SjD classification criteria. Participants completed baseline questionnaires of ocular symptoms and underwent ocular examinations. Differences in the ocular signs and symptoms between SjD and non-SjD groups were assessed. We used multivariable linear and linear mixed-effects models to investigate the impact of SjD on Ocular Surface Disease Index-6 and OSS., Results: Among 1532 participants classified as SjD, their Ocular Surface Disease Index-6 did not clinically differ from those classified as non-SjD (adjusted difference, -0.97; 95% confidence interval, -1.52 to -0.41). However, SjD participants exhibited an elevated ocular staining score (adjusted difference, 3.47; 95% confidence interval, 3.36-3.57; P < 0.001) compared with non-SjD participants. In addition, SjD was associated with increased odds of ocular signs, such as reduced tear break-up time, abnormal Schirmer I test, and corneal abnormalities, and was strongly related to more intense corneal and conjunctival staining, as well as additional corneal staining points., Conclusions: SjD is associated with a higher risk of ocular signs and pathology compared with non-SjD, whereas ocular symptoms remain similar. In addition, corneal abnormalities and corneal staining patterns could serve as a potential biomarker in identifying SjD-related dry eye.

Purpose: To evaluate how increasing age is associated with dry eye disease (DED) signs and symptoms in the Dry Eye Assessment and Management (DREAM) study. This study was undertaken to better understand how DED signs and symptoms differ across decades of life with goals to help assess detection and treatment of DED., Design: Secondary analysis of the DREAM study., Subjects: One hundred twenty, 140, 185, and 90 participants aged < 50, 50 to 59, 60 to 69, and ≥ 70 years, respectively., Methods: We performed a secondary analysis of data from the DREAM study, a multicenter randomized clinical trial, to evaluate the effect of omega-3 fatty acid supplementation for the treatment of DED. At baseline, 6 months, and 12 months follow-up, participants underwent an assessment of DED symptoms and signs using Ocular Surface Disease Index, Brief Pain Inventory, tear break-up time (TBUT) (in seconds), Schirmer test with anesthesia (mm/5 minutes), conjunctival staining, corneal staining, meibomian gland dysfunction evaluation, and tear osmolarity (mOsm/l). Multivariable generalized linear regression models were used to compare DED symptoms and signs across the 4 age groups among all participants and by sex., Main Outcome Measures: Scores of DED symptoms, individual signs, and composite scores of DED signs., Results: Among 535 patients with DED, increasing age was significantly associated with worse TBUT ( P  = 0.01), corneal staining ( P < 0.001), a composite severity score of DED signs ( P  = 0.007), and tear osmolarity ( P  = 0.001). Similar significant differences were found across 4 age groups of 334 women in TBUT, corneal staining score, composite severity score of DED signs, and tear osmolarity (all P < 0.05) but not in men., Conclusion: We found that corneal staining, TBUT, tear osmolarity, and a composite severity score of DED signs were significantly more severe with increasing age in women but not in men; worsening symptoms did not increase with increasing age., Financial Disclosures: The author(s) have no proprietary or commercial interest in any materials discussed in this article., (© 2023 Published by Elsevier Inc. on behalf of American Academy of Ophthalmology.)

Objective: Although symptom relief is a critical aspect for successful drug development in Sjögren's disease, patient experiences with Sjögren's-related symptoms are understudied. Our objective was to determine how pain, dryness, and fatigue, the cardinal symptoms of Sjögren's disease, drive cluster phenotypes., Methods: We used data from the Sjögren's International Collaborative Clinical Alliance (SICCA) Registry and a Sjögren's Foundation survey. We performed hierarchical clustering of symptoms by levels of dryness, fatigue, and pain. Using international and US cohorts, we performed multiple logistic regression analysis to compare the clusters, which included comparisons of differences in symptoms, quality of life (QoL), medication use, and systemic manifestations., Results: Four similar clusters were identified among 1,454 SICCA registrants and 2,920 Sjögren's Foundation survey participants: 1) low symptom burden in all categories (LSB); 2) dry with low pain and low fatigue (DLP); 3) dry with high pain and low to moderate fatigue (DHP); and 4) high symptom burden in all categories (HSB). Distribution of SICCA registrants matching the symptom profile for each cluster was 10% in the LSB cluster, 30% in the DLP cluster, 23% in the DHP cluster, and 37% in the HSB cluster. Distribution of survey participants matching the symptom profile for each cluster was 23% in the LSB cluster, 14% in the DLP cluster, 21% in the DHP cluster, and 42% in the HSB cluster. Individuals in the HSB cluster had more total symptoms and lower QoL but lower disease severity than those in the other clusters. Despite having milder disease as measured by laboratory tests and organ involvement, individuals in the HSB cluster received immunomodulatory treatment most often., Conclusion: We identified 4 symptom-based Sjögren's clusters and showed that symptom burden and immunomodulatory medication use do not correlate with Sjögren's end-organ or laboratory abnormalities. Findings highlight a discordance between objective measures and treatments and offer updates to proposed symptom-based clustering approaches., (© 2022 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objective: The objective of this study was to examine the association of smoking with Primary Sjögren syndrome (pSS) classification and pSS diagnostic test results. We hypothesized that past and current smokers would have lower odds of being classified as having Sjögren syndrome (SS) and lower odds of having abnormal individual SS diagnostic test results compared with nonsmokers., Methods: Participants with suspected or established pSS were enrolled into the Sjögren's International Collaborative Clinical Alliance (SICCA) registry and had oral, ocular, and rheumatologic examinations performed; blood and saliva samples collected; and labial salivary gland biopsy examinations performed; they also completed questionnaires at baseline. Logistic regression was used to determine whether smoking status was associated with pSS classification and individual pSS diagnostic test results., Results: A total of 3514 participants were enrolled in SICCA. A total of 1541 (52.9%) met classification criteria for pSS. Compared with never smokers, current smokers had reduced odds of being classified as having pSS, reduced odds of having a focus score ≥ 1 and serologic positivity for anti-SSA/anti-SSB antibodies, and lower odds of having abnormal signs or test results of dry eye disease. Compared with never smokers, past smokers did not have a statistically significant reduction in odds of being classified as having pSS and of having abnormal individual pSS diagnostic test results., Conclusion: Compared with never smokers, current smokers in the SICCA cohort had lower odds of being classified as having pSS, lower odds of exhibiting abnormal signs and test results for dry eye disease, and lower odds of having a labial salivary gland biopsy supportive of pSS classification. Such negative associations, however, do not suggest that current smoking is of any benefit with respect to pSS., (© 2021 The Authors. ACR Open Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Background: Although dupilumab has been associated with the development of conjunctivitis, little is known about other ocular surface disorders such as dry eye and how these side effects are managed., Objective: To evaluate the incidence and management of ocular surface disorders, including dry eye and conjunctivitis, among patients treated with dupilumab., Methods: Using US claims data, we evaluated the incidence of encounters for ocular surface disorders among patients treated with dupilumab. Secondary outcomes included ophthalmic medication use. A propensity score matched, active-comparator, new-user cohort design was used to compare the incidence of ocular surface disorders between those starting dupilumab versus methotrexate., Results: Among those with a history of atopic dermatitis, encounters for ocular surface disorders were more common in the 6 months after starting dupilumab than in the 6 months prior (11.7% versus 8.7%, P  < .001); 59.7% of those with a new ocular surface disorder diagnosis filled a prescription for an ophthalmic medication. The incidence of ocular surface disorders was higher among those treated with dupilumab than that in those treated with methotrexate (odds ratio 1.64; 95% confidence interval 1.17-2.30)., Limitations: Observational design., Conclusions: Dupilumab use for atopic dermatitis was associated with an increased risk of ocular surface disorders. Most patients who developed an ocular surface disorder received a prescription for an ophthalmic medication., Competing Interests: Dr Margolis was a member of joint Sanofi/Regeneron Data Safety and Monitoring Board for studies of dupilumab; he left the Data Safety and Monitoring Board about 2 years ago. He receives research funding to the Trustees of the University of Pennsylvania from the NIH-NIAMS and Valiant for unrelated studies of atopic dermatitis. He was on an advisory board sponsored by Leo, which disbanded about 2 years ago, and is currently a consultant for Leo both with respect to atopic dermatitis. Dr Bunya has served as a consultant for Verily and receives grant funding from 10.13039/100007489Bausch and Lomb for an unrelated study. Dr Massaro-Giordano has served as a consultant for Verily and was on advisory boards sponsored by Dompe and Lynthera. Author Barbieri has no conflicts of interest to declare. The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication., (© 2021 by the American Academy of Dermatology, Inc. Published by Elsevier Inc.)

Here we present a miniaturized analog of a blinking human eye to reverse engineer the complexity of the interface between the ocular system and the external environment. Our model comprises human cells and provides unique capabilities to replicate multiscale structural organization, biological phenotypes and dynamically regulated environmental homeostasis of the human ocular surface. Using this biomimetic system, we discovered new biological effects of blink-induced mechanical forces. Furthermore, we developed a specialized in vitro model of evaporative dry-eye disease for high-content drug screening. This work advances our ability to emulate how human physiological systems interface with the external world, and may contribute to the future development of novel screening platforms for biopharmaceutical and environmental applications.

Purpose: To determine whether signs and symptoms of ocular surface disease improve after placement of a self-retained, cryopreserved amniotic membrane (CAM) in patients with Sjögren syndrome (SS)., Methods: The medical records of SS patients who received a self-retained CAM implant (Prokera or Prokera Slim; TissueTech Inc, Doral, FL) for the treatment of ocular surface disease between August 2012 and August 2016 at a single, large academic institution were reviewed retrospectively. Visual acuity, results of slit-lamp examination of the cornea and conjunctiva, and dry eye symptoms, were evaluated before and after CAM insertion., Results: A total of 6 eyes of 6 patients (all female; mean age, 62.5 ± 13.0 years [range, 49-86 years]) were included. All patients were on topical medications at the time of the study and had signs of ocular surface dryness. There were reductions in corneal and/or conjunctival staining in 5 eyes (83%) after the CAM dissolved. All patients who completed therapy (5/5) experienced a relapse in their signs and symptoms within 1 month of removal of the CAM, with an average time to relapse of 24.6 days. Mean follow-up time was 54.5 days. Foreign body sensation and blurred vision were the most common complaints associated with the CAM implant., Conclusions: In this small case series, self-retained CAM implantation was found to be beneficial in SS patients with ocular surface disease that is refractory to standard therapies; however, we found that the effects were temporary. Future larger studies are needed to confirm these benefits.

Background: The Primary Sjögren's Syndrome Quality of Life questionnaire (PSS-QoL) is the first specific instrument to assess health-related quality of life (HRQoL) in Sjögren's disease (SjD). The aim is to translate and cross-culturally adapt the PSS-QoL into Brazilian Portuguese and to evaluate its psychometric properties., Methods: The original English version was translated into Brazilian Portuguese by two native Brazilians who were proficient in the English language. The retranslation was conducted by two native Americans proficient in Brazilian Portuguese. A committee undertook an analysis of the translated and retranslated versions, resulting in the generation of the first Brazilian version, which was submitted to the cross-cultural adaptation phase. In this phase, 50 participants with SjD responded to the instrument in Stages I and II, resulting in the generation of the second and final Brazilian version. To assess the psychometric properties, demographic and clinical data were collected from 75 patients. The HRQoL questionnaires (final Brazilian version of the PSS-QoL, Short Form-36 Health Survey (SF-36) and EuroQoL-5 dimension (EQ-5D)) were completed. Construct validity was analyzed using the Pearson or Spearman correlation coefficient. Reliability was analyzed using Cronbach's alpha and the intraclass correlation coefficient (ICC)., Results: Eight questions and one response item were revised due to an incomprehension rate of greater than 15% among the participants in the cross-cultural adaptation phase. The final Brazilian version of the PSS-QoL was validated, revealing a high correlation between the total score and functional capacity (r= -0.713, p < 0.001), and vitality (r= -0.770, p < 0. 001) and mental health (r= -0.742, p < 0.001) domains of the SF-36 and a moderate correlation with the other domains of the SF-36 and a moderate correlation with the EQ-5D-tto (r= -0.573, p < 0.001), and EQ-5D-VAS (r= -0.559, p < 0.001). The intraobserver (ICC = 0.939; Cronbach's alpha = 0.964) and interobserver (ICC = 0.965; Cronbach's alpha = 0.964) reliability of the total score showed very high consistency., Conclusion: The Brazilian version of the PSS-QoL has been demonstrated to be a valid and reproducible instrument for the assessment of HRQoL in patients with SjD., (© 2024. The Author(s).)

Background: Dry eye syndrome (DES) is common but lack of data in quality of life (QoL) of DES patients in Thailand. The primary outcome of this study was to determine QoL and health utility in patients of DES by EuroQol 5-domain (EQ-5D) of the 5-level version (5 L) instrument. The secondary outcome was comparison of the utility in the patients of DES classified by severity and causes including the autoimmune and non-autoimmune diseases. Method: The study was a cross-sectional study at a hospital in the northern part of Thailand. The inclusions DES patients were followed by Tear Film and Ocular surface Society the Dry Eye WorkShop II definition. The EQ-5D-5 L (Thai version) descriptive system and the EQ visual analogue scale (VAS) was instrument for QoL evaluation. Result: Total patients of DES were fifty-six. The most patients were female. The mean age was 57.7(± 13.9) years. The mean of EQ-5D-utility and EQ-VAS were 0.76 (± 0.18) and 72.56 (± 15.19), respectively. The mean of EQ-5D-utility in these patients who were classified by severity including mild, moderate and severe were 0.84 (± 0.16), 0.78 (± 0.14) and 0.71 (± 0.22), respectively. There is no statistic significant in the EQ-5D-utility and EQ-VAS among severity and the causes of these patients. Conclusions: This study demonstrated the importance of assessing QoL in DES. The EQ-5D-utility was accorded with the severity of DES. However, no statistic significant was showed in the mean of EQ-5D-utility and EQ-VAS between the severity and between the causes including the autoimmune and non-autoimmune diseases of these patients. [ABSTRACT FROM AUTHOR]

Introduction: Dry eye disease (DED) is a multifactorial condition of the ocular surface (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study. Methods: Patients were screened from days − 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days − 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire. Results: Seventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27–64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28 days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant. Conclusions: The PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes. Trial Registration: Brazilian National Research Ethics Commission (ReBEC registration number 16055). [ABSTRACT FROM AUTHOR]

Introduction: Dry eye disease (DED) is a frequently observed condition characterized by ocular discomfort and visual disturbance. It is highly prevalent and impairs patients' quality of life (QoL). This study assessed the benefit of a preservative-free bioprotectant eye drop formulation containing sodium hyaluronate and trehalose (SH-trehalose) with regards to DED, as well as patient satisfaction, through a large-scale real-life survey. Methods: In a multi-center, international, prospective observational study, subjects with DED received SH-trehalose for 84 days. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire-5 items (DEQ-5), and patient satisfaction were assessed at baseline, day 28, and day 84, and clinical evaluations included ocular surface staining, Schirmer test, tear film break-up time (TBUT), and conjunctival hyperemia at baseline and day 84. Results: A total of 312 patients were evaluated, of whom 82.4% were women. The mean age was 57.9 ± 15.2 years. The mean OSDI score at baseline was 41.7 ± 20.6. After 84 days, the mean OSDI score was 27.3 ± 19.8 (p < 0.001). The percentage of patients with a severe OSDI score decreased from 60.3 to 34.5%. The DEQ-5 score significantly (p < 0.001) improved after 28 and 84 days, as did patient satisfaction. Ocular surface staining, Schirmer test, TBUT, and conjunctival hyperemia scores improved significantly (all p < 0.001) for both eyes with SH-trehalose between baseline and day 84. Tolerance of SH-trehalose was good. Conclusions: SH-trehalose significantly improved the clinical signs and symptoms of DED after 84 days. Moreover, it significantly increased patient satisfaction and was well tolerated. Trial Registration: NCT04803240. [ABSTRACT FROM AUTHOR]

Background: To assess and compare the therapeutic outcomes of 0.05% Cyclosporine A (CsA) ophthalmic solution versus 0.1% Fluorometholone (FML) eyedrops in Chinese patients with mild dry eye disease (DED) unresponsive to conventional artificial tears (AT). Methods: A total of 43 patients with mild DED, who have failed to respond to conventional AT therapy for over 3 months, were randomly assigned to receive either 0.05% CsA or 0.1% FML twice daily for 6-months. In addition, all the patients were instructed to use 0.1% SH 4 times a day as supplementary therapy. Dry eye examination, including Ocular Surface Disease Index (OSDI) questionnaire, non-invasive tear break-up time (NIBUT), Schirmer scores, corneal fluorescein staining (CFS) scores, and conjunctival goblet cell (CGC) density, intraocular pressure (IOP), Best corrected visual acuity (BCVA) was conducted at baseline and then evaluated at 1, 3, and 6 months after treatment. Corneal endothelial cell density, corneal dendritic cells (DCs) and nerves were assessed by in vivo confocal microscopy at baseline and 6 months after treatment. Results: At 3 and 6 months after treatment, OSDI scores in the 0.05% CsA group showed more improvement than those in the 0.1% FML group. CFS was significantly lower and Schirmer scores were significantly higher in 0.05% CsA group compared with 0.1% FML group. NIBUT improved significantly in both groups, with greater improvement in the 0.05% CsA group at the 1-, 3-, and 6-month visits. Throughout the duration of the study, the 0.1% FML group exhibited no notable enhancement in CGC density. Conversely, a substantial elevation in CGC density was observed in the 0.05% CsA group. After 6 months of treatment, significantly reduced corneal DC density and area were obtained in 0.05% CsA group as compared to 0.1% FML group, while there were no significant changes in cornea nerve fiber density, cornea nerve fiber length and cornea nerve fiber width in both groups. Additionally, after 6 months of treatment, neither group showed any statistically significant changes in IOP, BCVA or in corneal endothelial cell density. Conclusion: The administration of 0.05% CsA proved effective in managing mild DED, offering a supplementary advantage in improving Schirmer scores, restoring CGC density and reducing corneal DC density compared to 0.1% FML eyedrops. Consequently, 0.05% CsA eyedrops are recommended as a safe and efficacious therapeutic alternative for patients with mild DED who fail to respond to conventional tear substitutes therapy. Clinical trial registration number: Chinese Clinical Trial Registry, ChiCTR2200066441, Registered 06 December 2022-Retrospectively registered. [ABSTRACT FROM AUTHOR]

Myocardial infarction (MI) is a leading cause of heart failure, disability and mortality worldwide. In this study, the effects of intramyocardial injection of human platelet lysate (HPL), bone marrow mesenchymal stem cells pretreated with HPL (PMSCs), and PMSC lysate (lys), alone and in combination were investigated on MI-induced by LAD ligation in male Wistar rats. The experiment was carried out on sham, vehicle (Veh), HPL, PMSCs, PMSC lysate (PMSC lys), HPL + PMSCs, and HPL + PMSC lys groups. SBP, DBP, and ± dp/dt max were monitored by the PowerLab physiograph. The MSC characteristics and CD31, NKX2.5, and cardiac troponin I (cTnI) contents were determined by flow cytometry, immunohistochemistry, and immunofluorescence, respectively. SBP, DBP, and ± dp/dt max that decreased in the MI group were recovered by HPL, PMSC, PMSC lys, HPL + PMSC, and HPL + PMSC lys treatments. CD31 density was higher in all treated groups compared to the Veh group. CD31 density in the HPL + PMSCs and HPL + PMSC lys groups was higher than in the PMSCs group. The number of Dil+/NKX2.5 + and Dil+/cTnI + cells was higher in the HPL + PMSCs group compared to the PMSCs group. The HPL and PMSCs mitigates heart injuries and cardiac dysfunction after MI. HPL provides an appropriate environment for cardiomyocyte differentiation from PMSCs. [ABSTRACT FROM AUTHOR]

Evaporation profiles have a strong effect on tear film thinning and breakup (TBU), a key factor in dry eye disease (DED). In experiments, TBU is typically seen to occur in patterns that locally can be circular (spot), linear (streak), or intermediate to those states. We investigate a two-dimensional (2D) model of localized TBU using a Fourier spectral collocation method to observe how the evaporation distribution affects the resulting dynamics of tear film thickness and osmolarity, among other variables. We find that the dynamics are not simply an addition of individual 1D solutions of independent TBU events, and we show how the TBU quantities of interest vary continuously between spots and streaks in the shape of the evaporation distribution. We also find a significant speedup by using a proper orthogonal decomposition to reduce the dimension of the numerical system. The speedup will be especially useful for future applications of the model to inverse problems, allowing the clinical observation at scale of quantities that are thought to be important to DED but not directly measurable in vivo within TBU locales. [ABSTRACT FROM AUTHOR]

Dry eye disease (DED) is a growing public health concern affecting millions of people worldwide and causing ocular discomfort and visual disturbance. Developing its therapeutic drugs based on animal models suffer from interspecies differences and poor prediction of human trials. Here, we established long‐term 3D human corneal epithelial organoids, which recapitulated the cell lineages and gene expression signature of the human corneal epithelium. Organoids can be regulated to differentiate ex vivo, but the addition of FGF10 inhibits this process. In the hyperosmolar‐induced DED organoid model, the release of inflammatory factors increased, resulting in damage to the stemness of stem cells and a decrease in functional mucin 1 protein. Furthermore, we found that the organoids could mimic clinical drug treatment responses, suggesting that corneal epithelial organoids are promising candidates for establishing a drug testing platform ex vivo. In summary, we established a functional, long‐term 3D human epithelial organoid that may serve as an ex vivo model for studying the functional regulation and disease modelling. [ABSTRACT FROM AUTHOR]

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]

Introduction: Despite an improved understanding of its pathogenesis, dry eye disease (DED) remains relatively underestimated and its treatment challenging. A better alignment between the clinical evaluation and the patient self-assessment also requires capturing the whole patient experience of DED. This project aimed to unveil this experience through narrative medicine (NM). Methods: The project involved 38 expert centres in Italy and one in San Marino, targeting adult patients with DED, their informal caregivers and their treating ophthalmologists. Written narratives and sociodemographic and quality of life (QoL)-related data were anonymously collected through the project's webpage. Narratives were analysed through MAXQDA (VERBI Software, Berlin, Germany), NM classifications and content analysis. Results: A total of 171 patients with DED, 37 informal caregivers and 81 ophthalmologists participated in the research. DED was defined as a disabling condition by 19% of patients and 35% of caregivers; 70% of patients reported that a therapeutic alliance is an integral part of DED treatment and 32% hope for more effective therapies. Forty-four per cent of patients assessed their own QoL as good; however, DED emerged as importantly impacting work performance and social events. DED physical, emotional and economic burden and the cruciality of a trusting care relationship represent the main themes that emerged across all narratives, while empathy and effective treatment are among the factors favouring coping with DED. Conclusion: This project marked a pioneering initiative investigating the lived experience of patients with DED through NM, simultaneously involving all viewpoints involved in the care pathway. NM enabled the unveiling of factors favouring the ability to cope with DED and its associated QoL implications and provided valuable insights to improve the therapeutic alliance. [ABSTRACT FROM AUTHOR]

Introduction: High-tech devices for the assessment of dry eye disease (DED) are increasingly available. However, the agreement between high- and low-tech parameters has been poorly explored to date. Trying to fill these gaps, we conducted a post hoc analysis on a recently published retrospective study on patients with DED receiving both low- and high-tech (Keratograph®) assessments, and treatment with different lubricating eyedrops. Methods: Six clinical questions were defined by the authors, considering literature gaps and their clinical experience, namely: (1) are NIKBUT-i and T-BUT interchangeable parameters? (2) What was the correlation between low- and high-tech parameters in untreated and treated patients with DED? (3) What was the correlation between signs and symptoms at baseline and during/after treatment? (4) Which parameters were better associated with symptoms? And with symptoms change over time? (5) What was the performance of NIKBUT-i and T-BUT in detecting clinically relevant changes? (6) What was the clinical advantage of adding other high- and low-tech parameters, respectively, to NIKBUT-i and T-BUT? Results: Low-tech measures were the best descriptors of the Ocular Surface Disease Index (OSDI) at baseline. In contrast, high-tech assessments demonstrate better performance in detecting changes over time. The distribution of NIKBUT-i data was more dispersed than TBUT both at baseline and follow-up. At a fixed specificity of 80%, the sensitivity in detecting clinically relevant ameliorations of symptoms was 42% for NIKBUT-i and 25% for T-BUT. A battery of high-tech tests could detect 90% of clinical amelioration, compared with 45% with low-tech tests (p < 0.001). Correlation between low- and high-tech parameters in both treated and untreated patients is lacking. Conclusions: Low-tech measures are adequate for diagnostic purposes in DED, whereas high-tech showed better performances at follow-up, particularly when different tests are combined. Overall, poor interchangeability among parameters and agreement with symptoms was reported both with high- and low-tech assessments. [ABSTRACT FROM AUTHOR]

Background: Sjögren's syndrome is an autoimmune disease characterized by sicca symptoms and various extraglandular manifestations including vasculitis. Neurological involvement occurs frequently (Neuro-Sjögren) and often mimics immune neuropathies such as chronic inflammatory demyelinating polyneuropathy (CIDP). Objectives: We aim to assess relevant differences in vessel density (VD) in Optical Coherence Tomography Angiography (OCTA) in those diseases to use it as an easily available diagnostic tool. Design: Prospective, monocentric pilot-study. Methods: OCTA (Heidelberg Engineering OCT SPECTRALIS) of the superficial vascular plexus, intermediate capillary plexus (ICP) and deep capillary plexus (DCP) of the retina was prospectively performed in Neuro-Sjögren, age-matched CIDP patients (n = 31, each), and healthy controls (n = 30). Vessel density (VD) and foveal avascular zone (FAZ) was measured with Erlangen Angio Tool. Results: Significantly lower VD were found for the DCP and ICP in Neuro-Sjögren and CIDP patients compared to healthy controls (p = 0.0002 and <0.0001). When group comparison was age-adjusted, these differences were not found anymore. Different frequencies of "low" retinal blood flow in each layer comparing Neuro-Sjögren and CIDP patients were not found. FAZ revealed no significant differences between patients with Neuro-Sjögren, CIDP and healthy controls. Conclusion: This study found no significant differences in VD or the foveal avascular zone between Neuro-Sjögren and CIDP patients using OCTA, suggesting that inflammatory vascular changes in the retina are uncommon in Neuro-Sjögren patients. [ABSTRACT FROM AUTHOR]

Background: Psychiatric disorders, such as major depressive disorder (MDD), anxiety disorder (AD), bipolar disorder (BD), and schizophrenia (SCZ), are disturbances in brain activity that lead to disorders of cognition, behavior, and emotion regulation. Among Sjogren syndrome (SS) patients, psychiatric disorders are more prevalent than in the general population. Identifying associated risk factors can provide new evidence for clinical diagnosis and treatment. Methods: We selected genetic instruments based on published genome-wide association studies (GWASs) to determine predisposition. Then, we conducted a 2-sample bidirectional Mendelian randomization (MR) analysis to explore the potential causal associations between SS and four major psychiatric disorders. The primary analysis was performed using MR with the inverse-variance weighted method. Confirmation was achieved through Steiger filtering and testing to determine the causal direction. Sensitivity analyses were conducted using MR-Egger, MR-PRESSO, and "leave-one-out" method methods. Results: Our study showed that SS was linked to BD and SCZ, indicating that individuals with SS may have a reduced risk of developing BD (IVW: OR = 0.940, P=0.014) and SCZ (IVW: OR = 0.854, P=1.47*10-4), while there was no causal relationship between SS and MDD or AD. MR-Egger regression shows no evidence of pleiotropy (BD: intercept = 0.007, p = 0.774; SCZ: intercept = 0.051, p = 0.209). The same as the MR-PRESSO analysis (BD: global test p = 1.000; SCZ: global test p = 0.160). However, the results from the leave-one-out analysis demonstrated instability. Specifically, after excluding SNP rs3117581, the effects on BD and SCZ were found to be non-significant, suggesting the potential influence of unrecognized confounding factors. The results of the reverse MR show that four major psychiatric disorders had no causal effects on SS. Conclusions: Our research findings demonstrate a causal relationship between SS and SCZ, as well as between SS and BD. There are no causal effects between the four major psychiatric disorders and SS. These findings suggest that SS may have the potential to reduce the risk of both psychiatric disorders. This study provides new insight for their prevention and treatment. [ABSTRACT FROM AUTHOR]

Background: Comprehensive research on the impact of various types of refractive errors (RE) and anisometropia on dry eye disease is still lacking. This study aimed to estimate the prevalence rates and potential lifestyle factors related to symptomatic dry eye (SDE) among adolescents in eastern China. Methods: A cross-sectional study was performed in 2023, and a stratified cluster sampling technique was used among adolescents in Nantong, China. Demographic information, including sex, age and BMI, were collected. All participants underwent optometric tests, while Ocular Surface Disease Index (OSDI) and self-designed questionnaires were administered. Both univariate and multivariate logistic regression analyses were used to assess associations between SDE and related parameters, and various types of RE and anisometropia were also included in the study. Results: A total of 1,518 participants were enrolled in the study, and the overall prevalence of SDE was 20.3% among adolescents in Nantong, China. Multiple logistic regression analyses showed that high myopia (aOR = 3.42, 95% CI = 1.60–3.36, p = 0.025), frequent use of eye drops (aOR = 2.31, 95% CI = 1.60–3.36, p<0.001), a history of allergic conjunctivitis (aOR = 1.93, 95% CI = 1.09–3.34, p = 0.025), and frequent blinking (aOR = 3.23, 95% CI = 2.31–4.53, p<0.001) were identified as risk factors for SDE. Conversely, male gender (aOR: 0.76, 95% CI: 0.58–0.99, p = 0.043), increased sleep time (6–7 h: aOR = 0.64, 95% CI = 0.46–0.89, p = 0.009; 7–8 h: aOR = 0.64, 95% CI = 0.43–0.95, p = 0.026; >8 h: aOR = 0.43, 95% CI = 0.23–0.82, p = 0.010), and timely intervention when vision decline occurred were protective factors against SDE (aOR = 0.61, 95% CI = 0.43–0.85, p = 0.004). Conclusion: High myopia was found to be independently associated with an increased risk of SDE., while hyperopia, astigmatism, and anisometropia were not independent risk factors for SDE. The identified risk and protective factors may help provide valuable insights for future research and interventions aimed at improving ocular health in adolescents. [ABSTRACT FROM AUTHOR]

Background: Dry eye disease (DED) is a prevalent condition affecting over 16 million patients in the USA. DED and the symptoms of ocular discomfort are debilitating and a significant burden on patients. If left untreated, DED can progress to cause severe pathology. Treatment is often initiated by patients without consulting a healthcare professional. This study investigated the safety and efficacy of a novel lipid-containing eye drop (BTC), which might better mimic the components of natural tears. Methods: This was a multicenter, randomized, double-masked, active control, two arm, parallel group study of eye drops in adult subjects with self-reported DED. Subjects were randomly assigned to BTC or control (commercially available non-lipid eye drops; NLED) arm and were followed for 30 days. Assessments using visual analog scale and patient-reported outcomes (PRO) questionnaires, non-invasive tear break up time, slit-lamp examination, and subject-reported ocular symptoms were conducted at baseline and at days 7 and 30. The primary endpoint was change in overall ocular comfort score from baseline to day 30. Results: 158 subjects were randomized, of whom 130 completed the study per protocol (PP). Mean (SD) age was 47.8 (14.14) years. The mean (95% CI) change in overall comfort scores at the 30-day follow-up in the PP population was 21.4 (15.1, 27.7) for the test drop and 10.0 (3.9, 16.1) for the comparator. The mean (95% CI) treatment difference was 11.3 (2.6, 20.1); this met the pre-defined requirements for non-inferiority. There was no significant difference in the proportion of eyes with reported ocular symptoms between the groups. At day 7, the OR (95% CI) was 0.967 (0.528, 1.770) and at day 30 was 1.160 (0.610, 2.203). There were no Grade 3 or higher corneal edema, corneal neovascularization, corneal staining, conjunctival injection, tarsal abnormalities or any other biomicroscopy findings, and no corneal infiltrates observed during the study. Conclusions: The investigational lipid eye drop BTC was noninferior to the commercially available non-lipid comparator in all parameters measured and has the potential to provide an effective therapy for subjects with symptoms of dry eye who would benefit from a lipid-based artificial tear. Trial Registration: NCT03995355 (http://www.clinicaltrials.gov), registered June 24, 2019. [ABSTRACT FROM AUTHOR]

Higher serum cholesterol levels have been associated with an increased risk of dry eye disease (DED). The relationship between statin (HMG‐CoA reductase inhibitor) use and DED in patients with hyperlipidemia remains unclear. To investigate the association between statin use and the risk of DED in patients with hyperlipidemia, we conducted a population‐based retrospective cohort study utilizing data from Taiwan's Longitudinal Generation Tracking Database. Patients were categorized into statin users and nonusers, with a 5‐year follow‐up period. The study identified patients with newly diagnosed hyperlipidemia, excluding those with prior DED diagnoses. Matching and adjustments for covariates resulted in 41,931 individuals in each group. Patients receiving statin therapy were compared with those unexposed. Cumulative exposure doses were also evaluated to assess dose–response relationships. The primary outcome was the incidence of DED diagnosed during the follow‐up period. Cox proportional hazards regression models estimated the risk of DED, and conditional logistic regression analyzed the dose–response effect of statin exposure. Among 41,931 matched pairs, statin users exhibited a slightly increased risk of developing DED compared with nonusers (adjusted hazard ratio, 1.06; 95% CI, 1.02–1.11; p < 0.01). However, no dose–response relationship was observed between statin exposure and DED risk. Statin use among patients with hyperlipidemia is associated with a marginally higher risk of DED. These findings underscore the importance of regular eye examinations in this patient population to facilitate early detection and management of DED. [ABSTRACT FROM AUTHOR]

Purpose: This prospective comparative study aimed to assess the effects on contact lens comfort, dryness, and wear time when symptomatic daily disposable (DD) contact lens (CL) wearers were refit with delefilcon A (DT1) lenses. Patients and Methods: Thirty five symptomatic DD CL wearers with dry eye disease as determined according to the TFOS DEWS 2 guidelines, were enrolled and completed the study. Participants wore their habitual DD CLs during an initial assessment and were subsequently refit with DT1 for 1 month. Participants were masked to the study lens type. Subjective ratings of end-of-day comfort and dryness, average wear time, and comfortable wear time were evaluated as primary endpoints. Results: Of the 35 participants, two participants were classified as aqueous deficient dry eye, while the remaining participants exhibited symptoms primarily due to evaporative causes. The median CLDEQ-8 score for dryness significantly improved from 17 (fair) with habitual lenses to 13 (good) with DT1 lenses (p < 0.01). Participants reported significantly better end-of-day comfort (p = 0.01) and less end-of-day dryness (p = 0.01) with DT1 compared to their habitual DD lenses. The comfortable wear time was significantly longer with DT1 (8.5 ± 4.1 hours) compared to habitual DD lenses (6.7 ± 3.2 hours) (p = 0.04). No significant differences were observed in vision ratings (p = 0.07). Conclusion: Refitting symptomatic DD CL wearers with DT1 resulted in improved end-of-day comfort, reduced end-of-day dryness, and extended comfortable wear time compared to their habitual lenses. These findings suggest that DT1 may offer benefits for symptomatic DD wearers with dry eye disease. [ABSTRACT FROM AUTHOR]

Introduction: Dry eye disease (DED) is one of the most prevalent eye conditions worldwide, with artificial tears serving as a primary treatment option. Despite their wide availability on the European market, there is a lack of established classifications based on their physicochemical properties. The aim of our study was therefore (i) to develop an analytical method that measures the concentration and the molecular weight (MW) of the hyaluronic acid (HA) in commercialized products, and (ii) to propose an overview based on their various physicochemical parameters. Methods: The intrinsic viscosity and MW of the HA, as well as osmolarity, pH, rheological profile, and viscosity, were measured or determined. A specific method was developed to measure the average intrinsic viscosity and HA content using a liquid size-exclusion chromatography system. The MW was determined using the Mark–Houwink equation. Results: Thirty-seven products commercialized in Europe were analyzed, with 21 of them containing HA. The HA MW was lowest (300 kDa) for Thealose®, Thealoz Duo® Gel, and Hyabak®, and highest (1300 kDa) for Vismed® Multi, Vismed® Gel, and Neovis® Gel. The pH values varied between 5.94 for Treovis® and 8.06 for Systane® Ultra. Osmolarity ranged between 148 mOsm/L and 325 mOsm/L for Neovis® and Treovis®, respectively. Viscosity was highly variable, ranging from 0.38 mPas·s for Hylolipid® to 337.47 mPas·s for Thealoz® Duo Gel. Finally, rheological profile analysis revealed different shear-thinning behaviors. Conclusion: While the perfect eye drop does not exist, a multitude of options are available to choose from. This study improves our understanding of the major tear substitutes available on the European market based on several physicochemical properties. A better understanding and awareness of these parameters is crucial in order to offer the best treatment for patients with DED. [ABSTRACT FROM AUTHOR]

Introduction: The purpose of this study is to assess the real-life efficacy and tolerance of a new preservative-free, surfactant-free latanoprost (PFSF-LAT) formulation. Methods: Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators' satisfaction were also assessed. Results: In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of − 5.5 ± 4.6 mmHg; − 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (− 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively. Conclusion: PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops. [ABSTRACT FROM AUTHOR]

Introduction: Patients with dry eye disease (DED) complain of a multitude of symptoms that affect their visual function and quality of life (QoL). This clinical investigation assessed the performance, tolerance, and safety of a novel preservative-free ophthalmic solution containing xanthan gum 0.2% and desonide sodium phosphate 0.025%. Methods: This was an observational, prospective, multicentric, and post-market clinical investigation to assess the effect of three times a day instillation of the study formulation in patients suffering from DED. The primary objective was to achieve a 50% reduction in conjunctival hyperemia index as assessed with the OCULUS Keratograph after 1 month of treatment compared to baseline values. The secondary objectives included patient-reported outcomes, clinical performance, and safety. Results: Thirty patients were enrolled (21 women, 9 men) with a mean age of 61.10 ± 14.53 years. The instillation of the study formulation was associated with a significant reduction in redness scores after 1 month of treatment compared to baseline (mean − 0.51 ± 0.51; p ≤ 0.0001). Although the primary endpoint was not completely met, a 50% reduction in the conjunctival hyperemia index was achieved in 23% of the participants, and 77% showed a reduction of 26% of the same index. In addition, the ophthalmic solution significantly increased tear film break-up time, and a significant reduction of corneal and conjunctival staining with fluorescein was achieved. It also reduced DED symptoms and had a very good safety profile. Conclusions: the study formulation produced a significant improvement in the signs, symptoms, and QoL of patients with mild to moderate DED with a good safety profile after 1 month of treatment. [ABSTRACT FROM AUTHOR]

To compare two types of lipid expression procedures to treat dry eye disease. Standardized treatment and evaluation methods were used in patients treated with either manual thermoelectric lipid expression (MiBoFlo) or automated lipid expression (Lipiflow) of the Meibomian glands. This was a contemporaneous, non-randomized study of both treatment methods. Treatment was per the manufacturers’ recommendation. The primary outcome included two types of dry eye questionnaires as well as objective analysis of ocular surface including tear break up time, Schirmer testing, Osmolarity, and fluorescein staining. Baseline characteristics analyzed included floppy lid, conjunctivochalasis and lagophthalmos. Statistical analysis was performed correcting for baseline factors such as age and co existing pathology using multivariable analysis. Both treatments improved the results of the OSDI and SPEED dry eye questionnaire results. Both treatments resulted in improvement of many objective findings including SPK, lissamine green staining and tear break up time with the MiBoFlo showing more improvement than Lipiflow. OSDI was more sensitive to improvement of symptoms than the SPEED questionnaire. Manual expression with MiBoFlo device resulted in statistically more improvement in questionnaire scores than did automated expression with Lipiflow. Negative prognostic factors for symptomatic improvement included blepharitis, autoimmune disease and ocular allergies. Thermal lid therapy along with mechanical expression of lipids from the meibomian glands successfully treats dry eye symptoms and signs. Manual therapy with MiBoFlo resulted in more subjective and objective improvement scores than automated therapy with the Lipiflow device. [ABSTRACT FROM AUTHOR]

Background: Dry eye syndrome (DES) is a widespread ocular condition affecting the general population. It is a complex disorder affecting the eye surface, characterized by a tear film imbalance and ocular symptoms such as eye ache, burning, irritation, dryness, blurred vision, and foreign body sensation. DES can reduce visual acuity, increase the risk of ocular infection, and significantly impact daily activities and quality of life. Aim: Determine the impact of nursing-led educational program on the management of DES and patients' health outcomes including the intensity of DES symptoms and their influence on visual-related functions. Methods: The study was conducted with a quasi-experimental design. Sixty adult patients diagnosed with DES were selected using a convenience sampling method. Two tools were employed for the collection of data. Tool I: Precipitating factors of DES structured interview schedule. Tool II: Ocular surface disease index (OSDI) to assess ocular irritation symptoms associated with DES and their effect on functions related to vision. Results: A statistically significant decrease in the mean scores of OSDI in the study group two weeks after the implementation of the educational program regarding the ocular symptoms, functions associated with vision, environmental triggers, and overall score of OSDI. Conclusion: Implementing an educational program for DES is effective in relieving symptoms, boosting patients' understanding of managing symptoms effectively, and maintaining eye health. Therefore, patients must be instructed on dry eye early detection and management to enhance health-related outcomes and self-care practices. Registration: ClinicalTrials.gov: NCT06288945. [ABSTRACT FROM AUTHOR]

Long-acting diquafosol ophthalmic solution (DQS-LX) has significant advantages regarding patient adherence owing to the reduced frequency of required eye drops; however, some patients prefer conventional diquafosol ophthalmic solution (DQS) over DQS-LX. Herein, to clarify the characteristics of patients according to their preference for ophthalmic solutions, dry eye (DE) and meibomian gland (MG) findings were retrospectively investigated. This study enrolled 341 patients with DE (mean age, 62.1 ± 11.7 years) treated at the Itoh Clinic between November 8, 2022, and July 31, 2023, who switched from DQS to DQS-LX. Patients were divided into two groups: those who continued DQS-LX administration (DQS-LX group) and those who wished to revert to conventional DQS (DQS group). Data regarding subjective symptoms assessed using the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film breakup time (BUT), tear meniscus height (TMH), corneal and conjunctival fluorescein staining (CFS), conjunctival hyperemia/papilla, meiboscore, plugging, vascularity, meibum grade, and Schirmer's score at the time of DQS-LX switch were evaluated. Of the 341 patients, 31 (9.1%) wished to revert to conventional DQS. In total, 16 eyes of 16 patients in the DQS group and 32 eyes of 32 patients in the DQS-LX group—for whom complete data were available—were included in the analysis. The DQS-LX group had higher SPEED scores, lower TMHs (P < 0.001, respectively), shorter FBUTs, greater CFS findings, larger meibum grades, lower Schirmer scores, and more pluggings compared with the DQS group (P = 0.005, 0.001, 0.001, 0.046, 0.003, respectively). Meiboscores and vascularity did not differ significantly between the two groups (P = 0.73 and 0.39, respectively). In conclusion, patients with low tear film volume and DE complicated by moderate or severe meibomian gland dysfunction (MGD) preferred DQS-LX, while those with allergic findings preferred conventional DQS. [ABSTRACT FROM AUTHOR]