epafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated with Cataract Surgery. European Study.
- Conditions
- ocular pain and inflammation associated with cataract extraction and intraocular lens implantation
- Registration Number
- EUCTR2005-002647-35-HU
- Lead Sponsor
- Alcon Research, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Adults (18 years of age or older) of any race, who have a cataract, and are expected to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber IOL.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Use of topical ocular or systemic steroids within 14 days prior to surgery.
Use of topical ocular, inhaled or systemic NSAIDs within 7 days of surgery (exception: low dose aspirin, up to 100mg, permitted).
Any intraocular inflammation or more than mild ocular pain at the baseline visit
Women of child-bearing potential who are breast-feeding, have a positive urine pregnancy test at baseline, or not using adequate birth control.
History of chronic or recurrent inflammatory eye disease in the operative eye.
Proliferative diabetic retinopathy or moderate to severe non-proliferative diabetic retinopathy in the operative eye; or uncontrolled diabetes mellitus.
Known or suspected allergy or hypersensitivity to NSAIDs, or any component of the study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and efficacy of nepafenac 0.1% eye drops, suspension compared to placebo with ketorolac trometamol 0.5% eye drops, solution (Acular) as a reference standard for the prevention and treatment of ocular pain and ocular inflammation after cataract extraction by phacoemulsification with posterior chamber IOL implanation;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method