Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

This study is currently recruiting participants.

Verified by Florida Eye Microsurgical Institute, May 2008

Sponsors and Collaborators:	Florida Eye Microsurgical Institute ISTA Pharmaceuticals
Information provided by:	Florida Eye Microsurgical Institute
ClinicalTrials.gov Identifier:	NCT00520260

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 IV

MedlinePlus related topics: Eye Diseases

Drug Information available for: Cyclosporin Cyclosporine Ketorolac Ketorolac tromethamine Bromfenac Bromfenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients

Further study details as provided by Florida Eye Microsurgical Institute:

Primary Outcome Measures:

Ocular comfort [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental bromfenac 0.09% BID for 6 weeks	Drug: bromfenac 0.09%, BID, 6 weeks
2: Active Comparator 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

Contacts

Contact: Barry A Schechter, MD

561-737-5500

bdsch77@aol.com

Locations

United States, Florida
Florida Eye Microsurgical Institute	Recruiting
Boynton Beach, Florida, United States, 33426
Contact: Barry Schechter, MD 561-737-5500
Principal Investigator: Barry A Schechter, MD

Sponsors and Collaborators

Florida Eye Microsurgical Institute

ISTA Pharmaceuticals

Investigators

Principal Investigator:

Barry Schechter, MD

Florida Eye Microsurgical Institute

More Information

Responsible Party:	Florida Eye Microsurgical Institute ( Barry Schechter, MD )
Study ID Numbers:	Sch012007
Study First Received:	August 21, 2007
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00520260
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Bromfenac
Cyclosporine
Eye Diseases

Ketorolac
Ketorolac Tromethamine
Cyclosporins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009