Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Phase 3
Completed
- Conditions
- Cataracts
- Interventions
- Other: Nepafenac vehicle eye drops
- Registration Number
- NCT00405730
- Lead Sponsor
- Alcon Research
- Brief Summary
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
Inclusion Criteria
- Patients (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Under 18.
- Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketorolac Trometamol Ketorolac Trometamol 5 mg/ml eye drops, solution One drop in the study eye 3 times daily for 23 days Nepafenac Nepafenac 1mg/ml eye drops, suspension One drop in the study eye 3 times daily for 23 days Nepafenac Vehicle Nepafenac vehicle eye drops One drop in the study eye 3 times daily for 23 days
- Primary Outcome Measures
Name Time Method Percentage of Patients with Day 14 Cure Day 14 Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bordeaux
馃嚝馃嚪Bordeaux, France