NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
Phase 2
Completed
- Conditions
- Dry Eye
- Interventions
- Drug: NOVA22007 ''Cyclosporine''Drug: vehicle/placebo
- Registration Number
- NCT00739349
- Lead Sponsor
- Santen SAS
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- Male and female 18 years and older
- Diagnosis of dry eye in both eyes
Exclusion Criteria
- Contraindications to the use of the study medications
- Known allergy or sensitivity to the study medications or their components
- Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
- Have participated in an investigational drug or device study within 30 days of Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 NOVA22007 ''Cyclosporine'' Cyclosporine 0.1% 1 NOVA22007 ''Cyclosporine'' Cyclosporine 0.05% 3 vehicle/placebo vehicle/placebo
- Primary Outcome Measures
Name Time Method Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions Approximately 13 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Central Maine Eye Care, PA
🇺🇸Lewiston, Maine, United States