Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520260
• Other study ID #: Sch012007
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2007
• Last updated: February 17, 2009
• Start date: August 2007
• Est. completion date: August 2008

Study information

• Verified date: February 2009
• Source: Florida Eye Microsurgical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Ocular Comfort

Intervention

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

Locations

Country	Name	City	State
United States	Florida Eye Microsurgical Institute	Boynton Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Eye Microsurgical Institute	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular comfort		six weeks