CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 881 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.

Search/NCT01853072
NCT01853072Phase 3Completed
CompareCT.gov

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

Alcon Research·interventional·Posted May 14, 2013·Updated Aug 3, 2016

In Brief

A Phase 3 clinical trial evaluating Nepafenac Ophthalmic Suspension, 0.3%, Nepafenac vehicle, and 1 other intervention for Non-Proliferative Diabetic Retinopathy and Cataract. Completed, enrolled 881 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 subjects following cataract surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Proliferative Diabetic Retinopathy, Cataract
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 14, 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

Test intervention

Nepafenac 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