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. - Nepafenac Ophthalmic E

Conditions: ocular pain and inflammation associated with cataract extraction and intraocular lens implantation

Registration Number: EUCTR2005-002647-35-PT

Lead Sponsor: Alcon Research, Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 225

Inclusion Criteria

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

Exclusion Criteria

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
Primary end point(s): Superiority of Nepafenac relative to placebo for percentage of patients with Day 14 aqueous flare score=0 and day 14 aqueous cells score=0 (i.e., clinical cures).;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: To evaluate the non-inferiority of Nepafenac relative to Ketorolac for the mean aqueous cells + flare score at day 21. Nepafenac compared to placebo and ketorolac for: percentage of patients declared to be treatment failures (based on cells, flare an ocular pain), investigator's assessment of ocular pain, percentage of patients with a clinically significant inflammation and eye drop confort evaluation at the Day 7 visit

Secondary Outcome Measures