Nepafenac Once Daily for Macular Edema - Study 1

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.

Timeline

Start

2013-06

Primary completion

2015-05

Completion

2015-05

Outcome

Met primary endpoint

registry Nepafenac vs Vehicle; p <0.001; Odds Ratio (OR) 2.1 (95% CI 1.5 to 3.0); Regression, Logistic NCT01853072 ↗

registry Nepafenac vs Vehicle; p <0.001; Odds Ratio (OR) 0.1 (95% CI 0.1 to 0.3); Regression, Logistic NCT01853072 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nepafenac	Other / unclassified	0.3 %	Topical
Background	Prednisolone	Other / unclassified	—	Topical

Indications