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New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.

ABSTRACT: INTRODUCTION:To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo®) on dry eye disease (DED) in patients undergoing cataract surgery. METHODS:Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT >?7, Schirmer I test >?15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 (V1), and 2 (V2) after surgery. VisuEvo® was self-administered three times daily for the whole study duration (group A); the control group (group B) had no tear substitute administration. The primary endpoint was the change in TBUT over time; the secondary endpoints were changes in Ocular Surface Disease Index (OSDI), ocular surface staining, the Schirmer I test, and osmometry. RESULTS:A total of 45 patients were included (group A, 23; group B, 22; age 74?±?8 years). At the screening, TBUT was similar between the groups (group A, 8.5?±?1.8 s; group B, 7.8?±?0.7, p?=?0.11). At the scheduled visits, TBUT increase vs screening visit was significantly higher in group A: +1.2 s at V0, +1.4 s at V1, and +1.9 s at V2 (p?

SUBMITTER: Fogagnolo P

PROVIDER: S-EPMC7140734 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.

Fogagnolo Paolo P Favuzza Eleonora E Marchina Daniele D Cennamo Michela M Vignapiano Roberto R Quisisana Chiara C Rossetti Luca L Mencucci Rita R

Advances in therapy 20200317 4

<h4>Introduction</h4>To evaluate the effects of a new lubricating, antioxidant solution (VisuEvo<sup>®</sup>) on dry eye disease (DED) in patients undergoing cataract surgery.<h4>Methods</h4>Patients requiring cataract surgery with either healthy ocular surface or mild DED (tear break-up time, TBUT > 7, Schirmer I test > 15 mm/5 min) were enrolled in this multicenter, open-label, randomized, prospective study. Scheduled visits were 2 weeks before surgery (screening), day of surgery (V0), week 1 ...[more]

PMID: 32185729

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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.

Dataset Information

New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.

Publications

New Therapeutic Strategy and Innovative Lubricating Ophthalmic Solution in Minimizing Dry Eye Disease Associated with Cataract Surgery: A Randomized, Prospective Study.

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