At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 169 enrolled
Drug / intervention
ISV-303 +3 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.
A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers
In Brief
A Phase 2 clinical trial evaluating ISV-303, DuraSite Vehicle, and 1 other intervention for Ocular Inflammation. Completed, enrolled 169 participants.
Detailed Summary
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedAug 2010
Primary CompletionJan 2011
TodayJul 2026
First PostedAug 30, 2010
Enrollment StartAug 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.8 years ago
Interventions
ISV-303drug
0.075% of bromfenac in DuraSite dosed QD
ISV-303drug
0.075% of bromfenac in DuraSite dosed BID
DuraSite Vehicledrug
Vehicle dosed BID
Xibrom™drug
0.09% bromfenac dosed BID