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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520260
Other study ID # Sch012007
Secondary ID
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
Health authority
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.

Study Design


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
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