NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen SAS
• Treatments: Cyclosporine; Cyclosporins

Criteria

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