Nevanac 3-Month Safety Study With QID Dosing

This study has been completed.

First Received: June 1, 2006 Last Updated: October 15, 2009 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00332774

Purpose

The purpose of this protocol is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following surgery.

Condition	Intervention	Phase
Cataract	Drug: Nevanac 0.1% Ophthalmic Suspension	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

Drug Information available for: Nepafenac

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Macular thickness

Secondary Outcome Measures:

contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters

Estimated Enrollment:	150
Study Start Date:	February 2006

Eligibility

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

Criteria

Inclusion Criteria:

Patients of any race or sex ages 10 years or older undergoing cataract extraction with planned implantation of a posterior chamber intraocular lens

Exclusion Criteria:

Under 10

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332774

Locations

United States, Texas
Fort Worth - United States
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director:

Stephen Lane

Medical Monitor

More Information

No publications provided

Study ID Numbers:	C-05-20
Study First Received:	June 1, 2006
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00332774 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Eye Diseases
Cataract
Lens Diseases

ClinicalTrials.gov processed this record on November 20, 2009