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

This study has been completed.

First Received on June 1, 2006. Last Updated on July 7, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00333255

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

Under 10

Contacts and Locations

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00333255 History of Changes
Other Study ID Numbers:	C-04-41
Study First Received:	June 1, 2006
Last Updated:	July 7, 2009
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012