Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Completed · Phase 4

Conditions studied: Dry Eye Disease, Ocular Comfort

In brief

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

Key facts

Study ID

NCT00520260

Run by

Florida Eye Microsurgical Institute

People needed

42

Starts

2007-08-01

Expected to finish

2008-08-01

Last updated by the study team

2009-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Florida Eye Microsurgical Institute — Boynton Beach, Florida, United States

Full record on ClinicalTrials.gov

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