Efficacy of 0.38% and 0.18% sodium hyaluronate ocular lubricants for dry eye: A randomized trial in adult gazan participants.

Rebamipide (OPC-12759) in the Treatment of Dry Eye: A Randomized, Double-Masked, Multicenter, Placebo-Controlled Phase II Study

The effect of time on grading corneal fluorescein and conjunctival lissamine green staining

Understanding the Dual Dilemma of Dry Eye and Glaucoma: An International Review.

To investigate symptom profiles and clinical signs in subjects with dry eye and normal subjects in a cross-sectional multicenter study. Subjects aged 35 to 65 were recruited according to dry eye diagnostic codes and telephone interview and completed the Dry Eye Questionnaire 2001, among others, and underwent dry eye clinical tests. Subjects (122) included 28 control subjects (C), 73 with non-Sjögren's keratoconjunctivitis sicca (non-SS KCS) and 21 with Sjögren's syndrome (SS). Subjects with SS or non-SS KCS reported discomfort and dryness most frequently and that many symptoms worsened over the day and were quite bothersome. Groups were significantly different in corneal fluorescein staining, conjunctival lissamine green staining, Schirmer 1 tear test, and tear break-up time (TBUT; chi2 and Kruskal-Wallis, P<0.0001). Statistically significant, but moderate, correlations were found between the frequency and evening intensity of dryness and discomfort and TBUT, Schirmer's tear test, overall corneal fluorescein staining, and temporal lissamine green conjunctival staining (Spearman r=0.31-0.45, P<0.01). Symptoms were moderately to highly correlated with the clinician's global grading of severity and highly correlated to patient's self-assessment of severity (r=0.46-0.86, P<0.0001), whereas signs showed lower correlations (r=0.22-0.46, P<0.0001). Subjects with SS or non-SS KCS reported frequent and intense ocular surface symptoms in the evening, some of which correlated moderately with clinical test results. The global clinician grade of dry eye correlated more highly with patient symptoms than did clinical signs, suggesting that patient symptoms influence dry eye diagnosis and grading of dry eye more than clinical test results.

This Issue At A Glance

The prevalence of dry eye disease (DED) is rising globally and needs to be urgently addressed by medical professionals because it lowers patients' quality of life. There are as yet no available data in the literature about the prevalence of and risk factors for DED in the Gaza Strip, a gap that the present study seeks to address. A cross-sectional study was carried out between March and August 2022 in Gaza governorates using a proportional stratified sampling technique. Only Gazan individuals ≥ 18 years old and able to follow the instructions were included. The Ocular Surface Disease Index (OSDI) questionnaire, which has previously been translated into Arabic and validated, was applied to evaluate DED symptoms. Subjective clinical tests for DED conducted were tear meniscus height (TMH), meibomian gland dysfunctions (MGDs), Marx line (ML), conjunctival Lissamine green staining (LGS), tear film break-up time test (TBUT), corneal fluorescein staining (CFS) and Schirmer II tear test (STT). DED was defined based on an Arab-OSDI score ≥ 13 and at least one positive clinical sign. A total of 426 participants were assessed from four areas (North Gaza Strip, 82; Gaza City, 147; Mid-Zone Gaza Strip, 62; South Gaza Strip, 135). The prevalence of DED in the present study was 31.5% (95% CI: 27.1, 36.1). Age > 50 years old (odds ratio [OR] = 10.45; 95% CI: 2.95, 37.05; P < 0.001), female gender (OR = 3.24; 95% CI: 1.40, 7.52, P = 0.006), menopause or pregnancy (OR = 2.59; 95% CI: 1.25, 5.35; P = 0.03) and pharmacotherapy (artificial tears; OR = 9.91; 95% CI: 2.77, 35.46; P < 0.001) were each associated with DED symptoms. South Gaza Strip (OR = 0.04; 95% CI: 0.01, 0.12; P < 0.001), unemployed (OR = 11.67; 95% CI: 1.43, 95.44; P = 0.02), non-consumption of caffeine (OR = 0.40; 95% CI: 0.19, 0.88; P = 0.02) and TMH < 0.2 (OR = 1.80; 95% CI: 1.02, 3.19; P = 0.04) were associated with TBUT < 5 s. LGS was associated with those > 50 years old (OR = 2.70; 95% CI: 1.38, 5.28; P = 0.004), previous refractive or ocular surface surgeries (OR = 2.97; 95% CI: 1.34, 6.59; P = 0.008) and CFS ≥ 1 (OR = 1.91; 95% CI: 1.07, 3.44; P = 0.03). Various aspects of DED were linked with different risk factors, suggesting that DED subtypes have different underlying pathophysiologies.

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

To determine whether tear osmolarity contributes to the assessment of the ocular surface in soft contact lens (CL) wearers. Prospective, case-control series in 44 CL wearers (28 tolerant and 16 intolerant) and 34 healthy subjects. Every patient underwent a thorough ophthalmic examination with a tear osmolarity test (TearLab System), conjunctival impression cytology and meibomian lipid sampling. Symptoms, break-up time (BUT), tear osmolarity, conjunctival expression of HLA-DR and meibomian fatty acid composition were evaluated. Tear osmolarity did not differ between controls and CL wearers (p= 0.23). Flow cytometry results expressed in antibody-binding capacity (ABC) units and percentage of positive cells revealed a significant difference between the intolerant CL wearer group and the control group (p< 0.0001). Comparisons between tolerant and intolerant CL wearers showed only a significant difference for mean fluorescence levels expressed in ABC units (p< 0.0001). The BUT was significantly shorter in intolerant and tolerant CL wearers subjects than in healthy subjects (p< 0.0001), whereas there was no significant difference in meibomian fatty acid composition (p= 0.99) between the two groups. Contact lens wear is responsible for ocular surface alterations whose patterns are very similar to those reported in early dry-eye syndrome. However, tear osmolarity was not modified in these selected CL wearers. The yield of tear osmolarity with TearLab™ in assessing ocular surface disorders in CL wearers deserves further investigation.

Lacrimal Gland-Associated Immune Deviation in the Rat

A Randomized, Multicenter Phase 3 Study Comparing 2% Rebamipide (OPC-12759) with 0.1% Sodium Hyaluronate in the Treatment of Dry Eye

The absence of a standardized diagnostic method for clinical signs of Dry Eye Disease (DED) complicates clinical trials for future treatments. This paper evaluated Lissamine Green (LG) conjunctival staining as a valid, stable and modifiable endpoint for both clinical practice and clinical trials. Screening and pre-randomization data from two identically designed clinical trials for DED resulted in a pooled dataset of 494 subjects. Inclusion was based on reported symptoms, lissamine green (LG) conjunctival staining, Fluorescein (Fl) corneal and conjunctival staining, and Schirmer's Test (ST). Outcome measures were assessed based on the modifiability of LG staining to exposure to a Controlled Adverse Environment (CAE®), correlation of LG to Fl staining, relative variation of LG staining scores and Schirmer test scores, and the correlation of LG staining with symptom scores. The modifiability of LG conjunctival staining to environmental exposure was demonstrated, with nasal LG and FL staining displaying the most similar percent change. Nasal LG conjunctival staining scores for subjects with ST scores of less than 8mm were significantly higher than for subjects with ST greater than 8mm. LG staining scores were more consistent (25% change from baseline threshold) than ST scores. Finally, statistically significant correlations were found between LG staining and a number of symptom scores. This evaluation demonstrates the superiority of the utilization of a clinical endpoint focused on ocular surface damage. The reproducibility and modifiability of LG conjunctival staining to controlled adverse environment, coupled with its significant correlation with symptoms, positions it as an exemplary clinical sign endpoint for clinical management and in clinical trials. Our findings advocate for the adoption of LG conjunctival staining as a primary endpoint in both clinical research and drug development, offering a more effective means of identifying and addressing ocular surface damage in the realm of DED.

Objective To study the expression of IL-1 beta on the ocular surface of dry eye patients and to study its correlation with symptoms and signs of dry eye; to investigate IL-1 beta's effect on dry eye pathogenesis.Methods Clinical trials.In this case-control study,30 dry eye patients (60 eyes) and 15 age-and gender-matched control subjects (30 eyes) without symptoms or signs of dry eye were selected from patients who had been treated in our hospital from September 2012 to February 2013.All subjects underwent full ophthalmologic examinations (including OSDI questionnaire,Schirrner's test (SIT),tear break-up time (BUT),corneal fluorescence staining and conjunctival lissamine green staining).Impression cytology was used to collect conjunctiva epithelial cells from dry eye patients and controls,then these samples were stained by IHC reaction to detect the expression of IL-1 beta by real-time PCR.Results The average OSDI questionnaire scores for the case group and controls were 24.1±2.2 and 14.3±1.3.SIT scores were 4.13±1.68 mm and 10.53± 0.74 mm.BUT times were 4.17±1.10 s and 8.80±1.21 s.Corneal fluorescence staining results were 4.3±1.5 and 0.6±0.5.Conjunctival lissamine green staining results were 5.7±2.0 and 1.9±1.4.There were significant differences between dry eye patients and control subjects (t=22.23,-19.88,-18.20,12.85,9.62,P＜0.05).The average expression of IL-1 beta in the case group and controls was 0.65± 0.37 and 0.22±0.06.There were significant differences between dry eye patients and control subjects (t=6.31,P＜0.05).The expression of IL-1 beta was positively correlated with scores on the OSDI questionnaire (r=0.81,P＜0.05),corneal fluorescence staining (r=0.58,P＜0.05),and conjunctival lissamine green staining (r=0.48,P＜0.05),and was negatively correlated with BUT (r=-0.45,P＜0.05) and SIT (r=-0.43,P＜0.05).With IHC staining,brown particles could be seen in the conjunctiva cells in patients with dry eye,but not in the controls.Conclusion IL-1β as an inflammatory mediator is involved not only in dry eye disease,but is also associated with the severity of dry eye and damage on the ocular surface. Key words: Interleukin-1 beta; Xerophthalmia; Impression cytology; Real-time polymerase chain reaction

Effect of hinge position on corneal sensation and dry eye after laser in situ keratomileusis using a femtosecond laser

Systemic Conditions Associated with Severity of Dry Eye Signs and Symptoms in the Dry Eye Assessment and Management Study

Objective: To determine the efficacy of Schirmer’s I test and TBUT test in dry eye changes in type II diabetic patients. Subjects&amp; Methods: In these prospective study 58 (116 eyes) dry eye patients with diabetesmellitus type II patients with minimum duration of 5 year, with BCVA of 6/12 to 6/6. After baseline examination, TBUT Test and Schirmer’s Test I were performed to measure dry eye changes occurred due to DM type II.As the data was not normally distributed therefore Wilcoxon sign rank test were applied using p-value ≤0.05 as significant. Results:In the current study on average duration of diabetes was 5.90±1.17 (Range 5-9)years. 30(50.8%) had 5 years history of diabetes, 15(25.4%) had 6years, 7(11.9%) has 7years, 4(6.8%) had 8years and 3(5.1%) had 9 years history of diabetes. Schirmer's Test I Ocular Dexter (OD) &amp;Oculus Sinister (OS) were 12.90±3.65mm and 12.56±3.23mm. Mean difference was statistically significant (p-value 0.022). Whereas mean TBUT of Ocular Dexter (OD) &amp;Oculus Sinister (OS) were 18.81±6.730 and 19.63±7.083 respectively, the mean difference was not statistically significant (p-value 0.342). Differences between TBUT &amp; Schirmer’s I test of OD and TBUT &amp; Schirmer’s I test of OS were statistically significant (p-value &lt;0.001). Conclusion: This study evaluates that TBUT Test are much significant as compared to Schirmer’s test because they have so much difference in their Mean ± Std. Deviation. Keywords: TBUT Test, Schirmer’s Test I, Diabetes type II, Dry Eye.