At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 223 enrolled
Drug / intervention
OMS302 Solution +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.
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
In Brief
A Phase 2 clinical trial evaluating OMS302 Solution, OMS302 Mydriatic Solution, and 2 other interventions for Cataract. Completed, enrolled 223 participants across 24 sites.
Detailed Summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCataract
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedSep 2010
Primary CompletionJan 2011
Study CompletionFeb 2011
TodayJul 2026
First PostedSep 1, 2010
Enrollment StartJul 1, 2010
Primary CompletionJan 1, 2011
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 15.8 years ago
Interventions
OMS302 Solutiondrug
OMS302 Mydriatic Solutiondrug
OMS302 Anti-inflammatory Solutiondrug
Balanced Salt Solution (BSS) Solutiondrug