NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
NCT00739349 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2016-06-06
Summary
Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.
Conditions
- Dry Eye
Interventions
- DRUG
-
NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
- DRUG
-
NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
- DRUG
-
vehicle/placebo
vehicle/placebo
Sponsors & Collaborators
-
Santen SAS
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-08-31
- Primary Completion
- 2009-01-31
- Completion
- 2009-01-31
Countries
- United States
Study Locations
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