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Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00348582
First Posted: July 4, 2006
Last Update Posted: June 25, 2007
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:
Innovative Medical
  Purpose
The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.

Condition Intervention Phase
Cataract Drug: Ketorolac, Nepafenac Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • · Male or female > 18 years of age scheduled to undergo cataract surgery

    • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
    • Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

  • · Known contraindication to any study medication or any of their components

    • Uncontrolled systemic disease
    • Required use of ocular medications other than the study medications during the study
    • Abnormal pre-operative OCTs if obtainable
    • Diabetic patients
    • Use of oral NSAIDS
    • Patients with ocular disease (macula degeneration, glaucoma, corneal disease) which reduces the potential visual rehabilitation (patients will ocular disease that will no preclude achievement of a 20/20 visual outcome may be included)..
  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): NCT00348582


Locations
United States, Pennsylvania
Dr. Francis
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Francis Mah, MD University Pittsburgh Medical Center Eye and Ear Institute
  More Information

ClinicalTrials.gov Identifier: NCT00348582     History of Changes
Other Study ID Numbers: 5217
First Submitted: June 30, 2006
First Posted: July 4, 2006
Last Update Posted: June 25, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Ketorolac
Nepafenac
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