Dry Eye Disease, Ocular Comfort
Conditions
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
Interventions
DRUGbromfenac
0.09%, BID, 6 weeks
DRUGketorolac
0.4%, BID, 6 weeks
Sponsors
Bausch & Lomb Incorporated
Florida Eye Microsurgical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular comfort | six weeks |
Countries
United States
Outcome results
None listed