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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00405730

First received: November 29, 2006

Last updated: April 3, 2012

Last verified: April 2012

History of Changes

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Tromethamine Tetrahydrozoline hydrochloride Boric acid Ketorolac Ketorolac tromethamine Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Percentage of Patients with Day 14 Cure [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.


Enrollment:	227
Study Start Date:	November 2005
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Under 18.
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405730

Locations


France
Bordeaux
Bordeaux, France, 33000

Sponsors and Collaborators

Alcon Research

More Information


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00405730 History of Changes
Other Study ID Numbers:	C-04-65 2005-002647-35
Study First Received:	November 29, 2006
Last Updated:	April 3, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Alcon Research:


Cataracts

Additional relevant MeSH terms:


Cataract Lens Diseases Eye Diseases Pharmaceutical Solutions Ophthalmic Solutions Tetrahydrozoline Ketorolac Ketorolac Tromethamine Nepafenac Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Nasal Decongestants Vasoconstrictor Agents Respiratory System Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016

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