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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00405730
• Collaborator: (none)
• Enrollment: 227
• Location: 1
• Arms: 3
• Duration (Months): 8
• Patients Per Site Per Month: 28.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Nepafenac 1mg/ml eye drops, suspension; Drug: Ketorolac Trometamol 5 mg/ml eye drops, solution; Other: Nepafenac vehicle eye drops	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 227 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Nov 1, 2005
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients with Day 14 Cure [Day 14]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bordeaux	Bordeaux		France	33000

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00405730
• Other Study ID Numbers: C-04-65; 2005-002647-35
• First Posted: Nov 30, 2006
• Last Update Posted: Nov 18, 2016
• Last Verified: Apr 1, 2012

• Keywords provided by Alcon Research: Cataracts
• Additional relevant MeSH terms: Cataract; Ketorolac; Ketorolac Tromethamine; Nepafenac; Ophthalmic Solutions

Study Results

No Results Posted as of Nov 18, 2016