Dataset Information

Efficacy of rebamipide 2% ophthalmic solution in the treatment of dry eyes.

ABSTRACT:

Aim

The aim of this study is to evaluate the efficacy of 2% rebamipide ophthalmic solution on the tear functions and ocular surface status in patients with dry eyes.

Materials and methods

A prospective study was carried out on forty eyes of patients having signs and symptoms of dry eye. Two percent rebamipide ophthalmic solution was applied four times a day for a period of 4 weeks. Patients were evaluated on the basis of dry eye-related symptom score, tear film break-up time (TFBUT), tear meniscus height, fluorescein ocular surface staining score (FOSS), and the Schirmer's test at the end of 2, 4, 6, and 12 weeks and their values were compared with the baseline.

Results

Significant improvement was noted in the mean dry eye-related symptom score, TBUT, and the FOSS values from the baseline at the end of 2, 4, 8, and 12 weeks. The values of tear meniscus height and Schirmer's test were improved at the end of 8 weeks but were not statistically significant.

Conclusion

Nearly 2% rebamipide ophthalmic solution provided relief in the symptoms of patients having dry eyes. It also prevented further ocular surface damage and aided in stabilizing the tear film.

SUBMITTER: Shrivastava S

PROVIDER: S-EPMC6219330 | biostudies-literature | 2018 Sep-Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy of rebamipide 2% ophthalmic solution in the treatment of dry eyes.

Shrivastava Saurabh S Patkar Priyanka P Ramakrishnan Reshma R Kanhere Minal M Riaz Zahna Z

Oman journal of ophthalmology 20180901 3

<h4>Aim</h4>The aim of this study is to evaluate the efficacy of 2% rebamipide ophthalmic solution on the tear functions and ocular surface status in patients with dry eyes.<h4>Materials and methods</h4>A prospective study was carried out on forty eyes of patients having signs and symptoms of dry eye. Two percent rebamipide ophthalmic solution was applied four times a day for a period of 4 weeks. Patients were evaluated on the basis of dry eye-related symptom score, tear film break-up time (TFBU ...[more]

PMID: 30505109

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Project description:BackgroundDry eye disease (DED) is a disorder characterized by loss of tear film homeostasis that causes ocular surface inflammation and damage. The incidence of DED increases with age. Cyclosporine ophthalmic solution 0.09% (CEQUA®; OTX-101), cyclosporine ophthalmic emulsion 0.05% (Restasis®; CsA), and lifitegrast ophthalmic solution 5% (Xiidra®; LFT) are anti-inflammatory agents indicated for DED. This analysis compared treatment patterns in patients with DED receiving OTX-101, CsA, or LFT.MethodsThis real-world, retrospective, longitudinal cohort study utilized Symphony Health Integrated Dataverse claims from July 2019 to June 2021. The dataset included all patients with OTX-101 claims and patients with CsA or LFT claims randomly selected 2:1 to OTX-101. Patients were sorted into 3 cohorts based on index treatment. Index date was that of first treatment claim, and follow-up period was from index date to end of clinical activity or data availability. Time to treatment discontinuation (TTD), probability of discontinuation, and treatment persistence were assessed for OTX-101 vs. CsA, then OTX-101 vs. LFT. Subgroup analysis was performed based on age and prior DED treatment. Kaplan-Meier analysis and log-rank test were used to examine TTD. A logistic model evaluated association between index treatment and discontinuation. Unadjusted and adjusted odds ratios, 95% confidence intervals, and P-values were reported, with statistically significant associations based on P-values < 0.05.ResultsOverall, 7102 patients (OTX-101 n = 1846; CsA n = 2248; LFT n = 3008) were eligible. Median TTD was 354 days for patients receiving OTX-101 vs. 241 days for CsA and 269 days for LFT. Log-rank test indicated TTD was significantly longer for patients on OTX-101 vs. CsA (P = 0.033). Patients on CsA were 35% more likely to discontinue treatment than patients on OTX-101; OTX-101 and LFT groups had similar discontinuation rates. After 360 days, 49.8% of patients receiving OTX-101 remained on treatment vs. 39.4% of patients on CsA (P = 0.036) and 44.0% of patients on LFT (P = 0.854).ConclusionsPatients receiving OTX-101 remained on treatment significantly longer and were significantly less likely to discontinue treatment than patients on CsA. Older patients remained on OTX-101 significantly longer than CsA. These findings highlight treatment pattern differences in patients with DED receiving these anti-inflammatory agents.

Project description:IntroductionThis study investigated the effect of rebamipide on discrepancies in the power and axis of astigmatism between two intra-patient keratometric measurements in patients with dry eyes.MethodsFifty-eight dry eyes (with a short tear breakup time [TBUT] of less than 5 s) were analyzed. Patients with dry eye were treated with 2% rebamipide ophthalmic suspension (group R) or Mytear® artificial tear ophthalmic solution (group M) for 4 weeks. TBUT and corneal higher-order aberrations (HOAs) were evaluated at baseline and 4 weeks after treatment. Astigmatism power and axis were measured twice during both evaluations, at 5-min intervals. Baseline and post-treatment measurements were compared. Changes in TBUT and HOAs, and intra-patient discrepancies in astigmatism power and axis measurements were evaluated.ResultsHOAs showed significant positive correlations with intra-patient differences in astigmatism power and axis (P < 0.001). At the 4-week post-treatment follow-up, TBUT increased, and HOAs and astigmatism power and axis discrepancies decreased in a significant number of patients in group R (P < 0.001). In group M, only differences in astigmatism power decreased in a significant number of cases (P = 0.005). The degree of change in the intra-patient difference in astigmatism power between the two post-treatment keratometric measurements was significantly greater in group R than in group M (P < 0.001). In group R, baseline HOAs exhibited a significant positive correlation with changes in HOAs and intra-patient differences in astigmatism power (both P < 0.001). In group M, baseline HOAs were only significantly correlated with changes in intra-patient differences in astigmatism power (P = 0.030).ConclusionIn dry eyes with short TBUTs, rebamipide significantly improved the corneal surface condition and significantly reduced intra-patient discrepancies in astigmatism power and axis measurements. Rebamipide may improve the accuracy of intraocular lens (IOL) power calculations in dry eyes, particularly when toric IOLs are implanted.

Project description:ObjectiveDry eye disease (DED) is a worldwide source of ocular discomfort. This first-in-human phase 2 clinical study determined the efficacy of treating signs and symptoms of DED using an ophthalmic solution of synthesized mimetic of human collagen (ST-100).DesignThis double-masked, randomized, study compared high (60 μg/mL) and low (22 μg/mL) dose ST-100 to vehicle utilizing the Ora, Inc. Controlled Adverse Environment (CAE) during a 28-day period.ParticipantsParticipants included males and females ≥ 18 years of age with signs and symptoms of DED for ≥ 6 months that worsened during CAE exposure who were not taking any topical prescription therapeutic.InterventionParticipants applied ST-100 or vehicle placebo topically to both corneas (1 drop) twice daily via a blow-fill-sealed preservative-free container.Main outcome measuresThe prespecified primary efficacy sign end point was mean change from baseline (CFB) in total corneal fluorescein staining, and the primary symptom end point was mean CFB in ocular discomfort. A secondary prespecified efficacy end point was CFB in unanesthetized Schirmer's test for tear film production.ResultsOf 160 subjects in the intent-to-treat population (112 female, 48 male, median age 64), 146 completed the study. Total corneal fluorescein staining CFB improved for high-dose ST-100, with superiority over vehicle when both eyes were considered together (2-sample t test: P = 0.0394). High-dose ST-100 was superior to vehicle in Schirmer's CFB for the study eye (least squares mean difference [confidence interval] = 2.3 [0.6, 4.0], P = 0.0094). For study eyes, the proportion of Schirmer's test responders (CFB ≥ 10 mm, Schirmer's responder rate) was 12.2% for high-dose ST-100 versus 0.0% for vehicle (P = 0.0266). The CFB for ocular discomfort score improved in study eyes for high- and low-dose ST-100 (paired t test, P = 0.0133, P = 0.0151, respectively) but without superiority over vehicle (ANCOVA: P = 0.5696, P = 0.8968, respectively). ST-100 Schirmer's responders also demonstrated total elimination of worsening of corneal fluorescein stain during the stress of CAE sessions.ConclusionsST-100 significantly improved tear production and related outcomes in DED and was well-tolerated in reducing symptoms.Financial disclosuresProprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Project description:ImportanceAn investigation of the treatment effect of lifitegrast ophthalmic solution, 5.0%, in different subgroups by severity of dry eye disease (DED) seems warranted.ObjectiveTo explore the heterogeneity across different subgroups of DED and identify which participants were most likely to achieve clinically meaningful benefit with lifitegrast treatment.Design, setting, and participantsThis post hoc responder analysis was performed using the data from the phase 3 OPUS-2 and OPUS-3 studies, which were 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials that previously demonstrated the efficacy of lifitegrast in DED. Pooled data were stratified into 4 subgroups based on severity of inferior corneal staining score (ICSS; ≤1.5 vs >1.5) and eye dryness score (EDS; <60 or ≥60) at baseline. Data were collected from December 7, 2012, to October 5, 2015, and post hoc analysis was performed from April 14, 2020, to July 30, 2021.InterventionsLifitegrast or placebo twice daily for 84 days.Main outcomes and measuresProportion of participants with (1) a clinically meaningful improvement in signs (ICSS or total corneal staining score [TCSS]) and symptoms (EDS or global visual analog scale [VAS]) and (2) a composite response for a given sign and symptom end point pair at day 84 were measured. Clinically meaningful improvement was defined as at least 30% improvement in symptoms (EDS or global VAS) and either at least a 1-point improvement in ICSS or at least a 3-point improvement in TCSS. For the composite responder analysis, the end point pairs were defined as at least a 30% reduction in EDS and at least a 1-point improvement in ICSS; at least a 30% reduction in EDS and at least a 3-point improvement in TCSS; at least a 30% improvement in global VAS and at least a 1-point improvement in ICSS; and at least a 30% improvement in global VAS and at least a 3-point improvement in TCSS.ResultsIn total, 1429 participants (716 in the placebo group and 713 in the lifitegrast group) were analyzed (1087 women [76.1%]; mean [SD] age, 58.7 [14.3] years). For the overall pooled population, responder and composite responder rates favored lifitegrast vs placebo (odds ratio range, 1.29 [95% CI, 1.05-1.59] to 2.10 [95% CI, 1.68-2.61]; P ≤ .02). In the composite analysis, the subgroup with ICSS of greater than 1.5 and EDS of at least 60 at baseline (ie, moderate to severe DED) demonstrated a 1.70- to 2.11-fold higher odds of achieving clinically meaningful improvement with lifitegrast across all sign and symptom end point pairs (P ≤ .001).Conclusions and relevanceThese post hoc findings suggest that lifitegrast ophthalmic solution, 5.0%, treatment may be associated with a response in participants with moderate to severe signs and symptoms of DED.Trial registrationClinicalTrials.gov Identifier: NCT02284516.

Dataset Information

Efficacy of rebamipide 2% ophthalmic solution in the treatment of dry eyes.

Aim

Materials and methods

Results

Conclusion

Publications

Efficacy of rebamipide 2% ophthalmic solution in the treatment of dry eyes.

Similar Datasets

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