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Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00333255

First Posted: June 2, 2006

Last Update Posted: July 8, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Alcon Research

Purpose

The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension, 0.1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating inflammation in the eye.

Condition	Intervention	Phase
Cataract	Drug: Nepafenac Ophthalmic Suspension, 0.1%	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment
Official Title:	Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).

Secondary Outcome Measures:

Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation


Enrollment:	267
Study Start Date:	September 2005
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:	10 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

Under 10

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333255

Locations


United States, Texas
Lehmann Eye Center
Nacogdoches, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators


Study Director:	Andrew Maxwell	Study Director

More Information


ClinicalTrials.gov Identifier:	NCT00333255 History of Changes
Other Study ID Numbers:	C-04-41
First Submitted:	June 1, 2006
First Posted:	June 2, 2006
Last Update Posted:	July 8, 2009
Last Verified:	July 2009

Additional relevant MeSH terms:


Inflammation Cataract Pathologic Processes Lens Diseases Eye Diseases Nepafenac Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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