Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

• Sponsor: Florida Eye Microsurgical Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00520260
• Collaborator: Bausch & Lomb Incorporated (Industry)
• Enrollment: 42
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease; Ocular Comfort	Drug: bromfenac; Drug: ketorolac	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Ocular comfort [six weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00520260
• Other Study ID Numbers: Sch012007
• First Posted: Aug 23, 2007
• Last Update Posted: Feb 19, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Ketorolac; Bromfenac

Study Results

No Results Posted as of Feb 19, 2009