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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00333255
First received: June 1, 2006
Last updated: July 7, 2009
Last verified: July 2009
  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
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:


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 April 16, 2014