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

This study has been completed.

First Received on November 29, 2006. Last Updated on July 31, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00405730

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
Cataract Surgery	Drug: Nepafenac	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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: Ketorolac Ketorolac tromethamine Nepafenac Tromethamine Tetrahydrozoline Tetrahydrozoline hydrochloride

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Percentage of patients with Day 14 cure (inflammation score = 0)

Secondary Outcome Measures:

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

Estimated Enrollment:	225
Study Start Date:	November 2005
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
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

Exclusion Criteria:

Under 18

Contacts and Locations

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

Locations

France
Bordeaux
Bordeaux, France, 33000

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Terry Wiernas

Alcon Research

More Information

No publications provided

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:	July 31, 2009
Health Authority:	France: Ministry of Health, France (AFSSPS)

Additional relevant MeSH terms:

Cataract
Lens Diseases
Eye Diseases
Tetrahydrozoline
Ketorolac
Ketorolac Tromethamine
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012