Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

Summary

A randomized, multicenter, double masked, placebo controlled, parallel group, bioequivalence study to evaluate the clinical equivalence and safety of Nepafenac 0.3% ophthalmic suspension (manufactured by Indoco remedies Ltd. for Actavis LLC) with IlevroTM (Nepafenac ophthalmic suspension), 0.3% of Alcon Laboratories, Inc. for the treatment of pain and inflammation associated with cataract surgery.

Timeline

Start

2018-03-28

Primary completion

2018-10-31

Completion

2018-12-18

Outcome

Met primary endpoint

registry analysis (superiority test); Nepafenac 0.3% Opthalmic Suspension vs Placebo (Vehicle) Opthalmic Suspension; p = 0.0005; ANOVA NCT03499873 ↗

Drugs

Indications