Confirmatory Study Nepafenac 0.3%

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the safety and efficacy of an investigational eye drop intended for the prevention and treatment of inflammation (swelling and redness) and pain in the eye after cataract extraction.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Nepafenac

Criteria

Inclusion Criteria:

• Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens;

• Patients who, in the opinion of the Investigator, would have improvement in best-corrected visual acuity after surgery;

• Able to understand and sign an informed consent;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Use of topical ocular, inhaled or systemic nonsteroidal anti-inflammatory drugs within 7 days of surgery, with the exception of the allowed low dose of aspirin (up to 100 mg) prior to surgery and through study exit;

• Use of topical ocular, inhaled or systemic steroids within 14 days prior to surgery and through study exit;

• History of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye;

• Diabetic retinopathy in the operative eye;

• Known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article;

• Other protocol-defined exclusion criteria may apply.