Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

Phase 3

Completed

• Conditions: Cataract

• Registration Number: NCT00333255
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2006-03
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-07
• Last Update Posted: 2009-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

• planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria

• Under 10

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation

Trial Locations

Locations (1)

Lehmann Eye Center; 🇺🇸 Nacogdoches, Texas, United States