Nepafenac Compared to Placebo for Ocular Pain and Inflammation
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|ClinicalTrials.gov Identifier: NCT01426854|
Recruitment Status : Completed
First Posted : September 1, 2011
Results First Posted : May 13, 2013
Last Update Posted : May 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Nepafenac Ophthalmic Suspension, 0.1% Other: Nepafenac Vehicle Ophthalmic Solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Surgery in Adult Chinese Subjects|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Active Comparator: Nepafenac
Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Drug: Nepafenac Ophthalmic Suspension, 0.1%
Topical ocular administration
Placebo Comparator: Placebo
Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
Other: Nepafenac Vehicle Ophthalmic Solution
Inactive ingredients used as placebo; topical ocular administration
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426854
|Zhongshan Ophthalmic Center, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Study Director:||Mandy Ye, Director||Alcon (China) Ophthalmic Product Co., Ltd.|