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 ]

Ocular inflammation was assessed by the Investigator during slit lamp examination. Aqueous cells were scored on a 5-unit scale from 0 (none) to 4 (>30 cells), and aqueous flare (protein escaping from dilated vessels) was scored on a 4-unit scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). To be considered cured, the patient must have had a score of 0 for both aqueous cells and aqueous flare. The proportion of subjects with a clinical cure is reported as percentage.


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 ]

Ocular pain is defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The Investigator scored ocular pain based on the description of pain by the subject. Pain was scored on a 6-unit scale ranging from 0 (none, absence of positive sensation) to 5 (severe, subject reports intense ocular, periocular or radiating pain requiring prescription analgesic). To be considered pain-free at all post operative visits, the patient must have had a score of 0 at Days 1, 3, 7, and 14 and any unscheduled visit. The proportion of subjects who were pain-free at all post-operative visits is reported as percentage.


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