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Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Information source: Florida Eye Microsurgical Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dry Eye Disease; Ocular Comfort

Intervention: bromfenac (Drug); ketorolac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Florida Eye Microsurgical Institute

Official(s) and/or principal investigator(s):
Barry Schechter, MD, Principal Investigator, Affiliation: Florida Eye Microsurgical Institute

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

Clinical Details

Official title: Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Ocular comfort

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Florida Eye Microsurgical Institute, Boynton Beach, Florida 33426, United States
Additional Information

Starting date: August 2007
Last updated: February 17, 2009

Page last updated: August 23, 2015

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