At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 307 enrolled
Drug / intervention
Vehicle Ophthalmic Solution +2 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 Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Phase 2 Study of the Efficacy and Safety of RTA 408 For the Prevention of Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
In Brief
A Phase 2 clinical trial evaluating Vehicle Ophthalmic Solution, Omaveloxolone Ophthalmic Suspension 0.5%, and 1 other intervention for Corneal Endothelial Cell Loss and 3 related conditions. Completed, enrolled 307 participants across 15 sites.
Detailed Summary
This study assesses the efficacy and safety of two concentrations of omaveloxolone (RTA 408) ophthalmic suspension for the prevention of corneal endothelial cell loss following cataract surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAbbVie
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartMay 2014
Primary CompletionFeb 2015
Study CompletionApr 2015
TodayJul 2026
First PostedMay 1, 2014
Enrollment StartMay 31, 2014
Primary CompletionFeb 28, 2015
Study CompletionApr 30, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.2 years ago
Interventions
Vehicle Ophthalmic Solutiondrug
Opthalmic suspension manufactured to mimic RTA 408 suspension
Omaveloxolone Ophthalmic Suspension 0.5%drug
0.5% ophthalmic suspension of RTA 408
Omaveloxolone Ophthalmic Suspension 1%drug
1% ophthalmic suspension of RTA 408