Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

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. Identifier: NCT00520260
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : February 19, 2009
Bausch & Lomb Incorporated
Information provided by:
Florida Eye Microsurgical Institute

Brief Summary:
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease

Condition or disease Intervention/treatment Phase
Dry Eye Disease Ocular Comfort Drug: bromfenac Drug: ketorolac Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Study Start Date : August 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Active treatment arm bromfenac 0.09% BID for 6 weeks
Drug: bromfenac
0.09%, BID, 6 weeks
Active Comparator: 2
ketorolac 0.4% BID for 6 weeks
Drug: ketorolac
0.4%, BID, 6 weeks

Primary Outcome Measures :
  1. Ocular comfort [ Time Frame: six weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be in general good health
  • Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

  • Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
  • Patients who are pregnant or nursing females
  • Unwilling to discontinue use of contact lenses during the run-in and duration of the study
  • Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
  • Previous treatment failure on CSA 0.05% (Restasis)
  • Known hypersensitivity to any component of the study or procedural medications
  • Participation in any other clinical trial within 30 days prior to screening
  • Known contraindication to any study medication or any of their components.
  • Should not be taking any oral anti-histamines, beta blockers or diuretics.

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 identifier (NCT number): NCT00520260

United States, Florida
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States, 33426
Sponsors and Collaborators
Florida Eye Microsurgical Institute
Bausch & Lomb Incorporated
Principal Investigator: Barry Schechter, MD Florida Eye Microsurgical Institute

Responsible Party: Barry Schechter, MD, Florida Eye Microsurgical Institute Identifier: NCT00520260     History of Changes
Other Study ID Numbers: Sch012007
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ketorolac Tromethamine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents