EUCTR2005-002647-35-GBActive, not recruitingPhase 1
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.
Alcon Research, Ltd0 sites0 target enrollmentStarted: September 22, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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