At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Nepafenac 0.3% Oph Susp, Placebos, and 1 other intervention for Cataract. Completed, enrolled 448 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Nepafenac 0.3% Ophthalmic suspension (experimental product)
Placebo
Nepafenac 0.3% Ophthalmic suspension (Innovator)