Clinical Trial: Nepafenac Compared to Placebo for Ocular Pain and Inflammation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Evaluation of Safety and Efficacy of Nepafenac Ophthalmic Suspension, 0.1% Compared to Placebo for the Prevention and Treatment of Ocular Inflammation and Pain Associated With Cataract Surger
Brief Summary: The purpose of this study was to demonstrate that Nepafenac Ophthalmic Suspension, 0.1% is superior to Nepafenac Vehicle (placebo) for the prevention and treatment of ocular inflammation and pain associated with cataract surgery in Chinese subjects.
Detailed Summary:
Sponsor: Alcon Research
Current Primary Outcome: Proportion of Subjects With Clinical Cure at Day 14 [ Time Frame: Day 14 postoperative ]
Original Primary Outcome: Proportion of subjects with clinical cure at Day 14 where clinical cure is defined as a score of 0 for both aqueous cells and flare. Cochran-Mantel-Haenszel (CMH) test will be used to assess differences between treatment groups. [ Time Frame: 14 days (Day 14) after cataract extraction ]
Current Secondary Outcome: Proportion of Subjects Who Were Pain-Free at All Postoperative Visits [ Time Frame: Up to Day 14 ]
Original Secondary Outcome: Proportion of subjects with an Investigator's ocular pain score of 0 at all post-operative visits. CMH test will be used to assess differences between treatment groups. [ Time Frame: Day 1, 3, 7, 14 after cataract extraction ]
Information By: Alcon Research
Dates:
Date Received: August 30, 2011
Date Started: July 2011
Date Completion:
Last Updated: May 10, 2013
Last Verified: May 2013