CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
ISV-305 +1 moredrug
Likely dose
ISV-305 0.1% dexamethasone in DuraSite® 2 applied topically twice daily for 16 daysAI-extracted
Key inclusion· 4
  • ✓At least 17 years of age
  • ✓Scheduled for uncomplicated unilateral cataract surgery
  • ✓Willing and able to follow all instructions and attend all study visits
  • ✓Willing to avoid disallowed medication for the duration of the study
Key exclusion· 10
  • ✕Known sensitivity or poor tolerance to any component of the study drugs
  • ✕Any sign of iritis or scleritis in the study eye
  • ✕Acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
  • ✕Any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)

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

Search/NCT03192137
NCT03192137Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Multicenter, Double-masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (0.1% Dexamethasone in DuraSite® 2) to DuraSite 2 Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Sun Pharmaceutical Industries Limited·interventional·Posted Jun 19, 2017·Updated Nov 19, 2021

In Brief

A Phase 3 clinical trial evaluating ISV-305 and Vehicle for Inflammation and Pain Associated With Cataract Surgery. Completed, enrolled 260 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation and Pain Associated With Cataract Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 19, 2017
Enrollment StartJan 30, 2018
Primary CompletionApr 17, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 9.0 years ago

Interventions

ISV-305drug

Dexamethasone in DuraSite® 2 twice daily for 16 days

Vehicleother

Vehicle twice daily for 16 days