Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Overview

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

Full Title of Study: “Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2008

Interventions

  • Drug: bromfenac
    • 0.09%, BID, 6 weeks
  • Drug: ketorolac
    • 0.4%, BID, 6 weeks

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Active treatment arm bromfenac 0.09% BID for 6 weeks
  • Active Comparator: 2
    • ketorolac 0.4% BID for 6 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Ocular comfort
    • Time Frame: six weeks

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Florida Eye Microsurgical Institute
  • Collaborator
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Barry Schechter, MD, Florida Eye Microsurgical Institute
  • Overall Official(s)
    • Barry Schechter, MD, Principal Investigator, Florida Eye Microsurgical Institute

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