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

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

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 Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Drug: Nepafenac 1mg/ml eye drops, suspension; Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution; Other: Nepafenac vehicle eye drops

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nepafenac; One drop in the study eye 3 times daily for 23 days	Drug: Nepafenac 1mg/ml eye drops, suspension; One drop in the study eye 3 times daily for 23 days
Active Comparator: Ketorolac Trometamol; One drop in the study eye 3 times daily for 23 days	Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution; One drop in the study eye 3 times daily for 23 days
Placebo Comparator: Nepafenac Vehicle; One drop in the study eye 3 times daily for 23 days	Other: Nepafenac vehicle eye drops; One drop in the study eye 3 times daily for 23 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients with Day 14 Cure	Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.	Day 14

Collaborators and Investigators

• Sponsor: Alcon Research

Publications and helpful links

General Publications

• Nardi M, Lobo C, Bereczki A, Cano J, Zagato E, Potts S, Sullins G, Notivol R. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007 Dec;1(4):527-33.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 1, 2006

Study Registration Dates

• First Submitted: November 29, 2006
• First Submitted That Met QC Criteria: November 29, 2006
• First Posted (Estimate): November 30, 2006

Study Record Updates

• Last Update Posted (Estimate): November 18, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Cataracts
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Pharmaceutical Solutions; Ketorolac; Ophthalmic Solutions; Ketorolac Tromethamine; Nepafenac
• Other Study ID Numbers: C-04-65; 2005-002647-35