Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract Surgery
Intervention: Nepafenac (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Terry Wiernas, Study Director, Affiliation: Alcon Research
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
Clinical Details
Official title: Nepafenac 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Percentage of patients with Day 14 cure (inflammation score = 0)
Secondary outcome: Mean aqueous cells and flare scores, percentage of treatment failures and of patients with clinically significant inflammation, and assessment of ocular pain, at each visit
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Exclusion Criteria:
- Under 18
Locations and Contacts
Bordeaux, Bordeaux 33000, France
Additional Information
Starting date: November 2005
Last updated: April 21, 2008
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