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Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Florida Eye Microsurgical Institute
ClinicalTrials.gov Identifier:
NCT00520260
First received: August 21, 2007
Last updated: February 17, 2009
Last verified: February 2009
History of Changes
  Purpose

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 Intervention Phase
Dry Eye Disease
Ocular Comfort
 Drug: bromfenac
Drug: ketorolac
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Florida Eye Microsurgical Institute:

Primary Outcome Measures:
  • Ocular comfort [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: August 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520260

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

No publications provided

Responsible Party: Barry Schechter, MD, Florida Eye Microsurgical Institute
ClinicalTrials.gov Identifier: NCT00520260     History of Changes
Other Study ID Numbers: Sch012007
Study First Received: August 21, 2007
Last Updated: February 17, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013