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
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, see Learn About Clinical Studies.

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:
Cataract
Inflammation
Eye Diseases
Lens Diseases
Pathologic Processes
Nepafenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014