Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo

Alcon Research227 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

227

Conditions

Cataracts

Interventions

Nepafenac 1mg/ml eye drops, suspensionDRUG

One drop in the study eye 3 times daily for 23 days

Ketorolac Trometamol 5 mg/ml eye drops, solutionDRUG

One drop in the study eye 3 times daily for 23 days

Nepafenac vehicle eye dropsOTHER

One drop in the study eye 3 times daily for 23 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bordeaux

Bordeaux, France

Outcomes

Primary Outcomes

Percentage of Patients with Day 14 Cure

Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.

Time frame: Day 14

Data from ClinicalTrials.gov

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