drugset / Trial / NCT01872611

Nepafenac Once Daily for Macular Edema - Study 2

NCT01872611 ↗

Phase 3 Completed 819 enrolled Alcon Research
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2013-06
Primary completion
2015-05
Completion
2015-05

Outcome

Mixed primary results

registry NUMBER Nepafenac: 48.8 Percentage of participants NUMBER Vehicle: 50.5 Percentage of participants analysis (superiority or other test); Nepafenac vs Vehicle; p = 0.671 NCT01872611 ↗

registry NUMBER Nepafenac: 5.9 Percentage of participants NUMBER Vehicle: 14.3 Percentage of participants analysis (superiority or other test); Nepafenac vs Vehicle; p = 0.001 NCT01872611 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Nepafenac Other / unclassified 0.3 % Topical
Background Prednisolone Other / unclassified — Topical