CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 268 enrolled
Drug / intervention
ISV-303 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01808547
NCT01808547Phase 3Completed
CompareCT.gov

A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Sun Pharmaceutical Industries Limited·interventional·Posted Mar 11, 2013·Updated Nov 19, 2021

In Brief

A Phase 3 clinical trial evaluating ISV-303 and DuraSite Vehicle for Ocular Inflammation. Completed, enrolled 268 participants.

Detailed Summary

The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2013
Enrollment StartMay 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 13.3 years ago

Interventions

ISV-303drug

0.075% bromfenac in DuraSite dosed BID

DuraSite Vehicleother

DuraSite vehicle dosed BID