drugset / Trial / NCT01543490

Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects

NCT01543490 ↗

Phase 3 Completed 558 enrolled Sun Pharmaceutical Industries, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.

Timeline

Start
2018-03-30
Primary completion
2020-02-04
Completion
2020-02-04

Outcome

Met primary endpoint

registry analysis (superiority test); ISV-305 vs Vehicle; p = 0.0354; Risk Difference (RD) 8.5 (95% CI 0.2 to 16.6); Fisher Exact; NCT01543490 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.1 % —

Indications