drugset / Trial / NCT03192150

2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

NCT03192150 ↗

Phase 3 Completed 246 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 to Vehicle in the treatment of inflammation and pain associated with cataract surgery.

Timeline

Start
2018-01-03
Primary completion
2019-11-18
Completion
2019-11-18

Outcome

Met primary endpoint

registry analysis (superiority test); ISV-305 vs Vehicle; p < 0.0001 NCT03192150 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 % Topical