NCT03499873

Clinical Endpoint Study of Nepafenac 0.3% Opthalmic Suspension

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 448 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Nepafenac 0.3% Oph Susp	Nepafenac 0.3% Ophthalmic suspension (experimental product)
DRUG	Placebos	Placebo
DRUG	Nepafenac 0.3% Oph Susp (reference)	Nepafenac 0.3% Ophthalmic suspension (Innovator)

Timeline

• Start date: 2018-03-28
• Primary completion: 2018-10-31
• Completion: 2018-12-18
• First posted: 2018-04-17
• Last updated: 2021-02-16
• Results posted: 2021-02-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study