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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.
Information provided by:
Alcon Research Identifier:
First received: June 1, 2006
Last updated: July 7, 2009
Last verified: July 2009
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
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)

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

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 identifier: NCT00333255

United States, Texas
Lehmann Eye Center
Nacogdoches, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Study Director: Andrew Maxwell Study Director
  More Information 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:
Pathologic Processes
Lens Diseases
Eye Diseases
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on October 21, 2016