Conditions: Cataract
Keywords: Cataract Surgery Anti-ocular Inflammation Anti-ocular Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 260
Healthy volunteers: no

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 description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Nepafenac Ophthalmic Suspension, 0.1% intervention 2: Nepafenac Vehicle Ophthalmic Solution
Intervention descriptions: intervention 1: Topical ocular administration intervention 2: Inactive ingredients used as placebo; topical ocular administration

Protocol document: