drugset / Trial / NCT03192137

Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

NCT03192137 ↗

Phase 3 Completed 260 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.

Timeline

Start
2018-01-30
Primary completion
2019-04-17
Completion
2019-04-17

Outcome

Met primary endpoint

registry analysis (superiority test); ISV-305 vs Vehicle; p = 0.0005; Chi-squared, Corrected NCT03192137 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 % Topical