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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333255
First Posted: June 2, 2006
Last Update Posted: July 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Alcon Research
  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
Intervention Model: Parallel Assignment
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • planned cataract extraction with posterior chamber intraocular lens implantation

Exclusion Criteria:

  • Under 10
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00333255     History of Changes
Other Study ID Numbers: C-04-41
First Submitted: June 1, 2006
First Posted: June 2, 2006
Last Update Posted: July 8, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Nepafenac
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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


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