At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 819 enrolled
Drug / intervention
Nepafenac Ophthalmic Suspension, 0.3% +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.
Randomized, Double-Masked, Vehicle Controlled, Clinical Evaluation To Assess The Safety And Efficacy Of Nepafenac Ophthalmic Suspension, 0.3% For Improvement In Clinical Outcomes Among Diabetic Subjects Following Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Nepafenac Ophthalmic Suspension, 0.3%, Vehicle, and 1 other intervention for Non-Proliferative Diabetic Retinopathy and Cataract. Completed, enrolled 819 participants.
Detailed Summary
The purpose of this study is to demonstrate superiority of Nepafenac Ophthalmic Suspension, 0.3% dosed once daily relative to Nepafenac Vehicle based upon clinical outcomes among diabetic participants following cataract surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Proliferative Diabetic Retinopathy, Cataract
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJun 2013
First PostedJun 2013
Primary CompletionMay 2015
TodayJul 2026
First PostedJun 7, 2013
Enrollment StartJun 1, 2013
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.1 years ago
Interventions
Nepafenac Ophthalmic Suspension, 0.3%drug
Vehicleother
Inactive ingredients used as placebo comparator
Prednisolone acetatedrug
1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks