NCT00739349

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

A Phase II, Multi-Center, Double-Masked, Randomized Study of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions Compared to Vehicle for the Treatment of the Signs and Symptoms of Dry Eye

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Santen SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	NOVA22007 ''Cyclosporine''	Cyclosporine 0.05% Ophthalmic Cationic Emulsions
DRUG	NOVA22007 ''Cyclosporine''	Cyclosporine 0.1% Ophthalmic Cationic Emulsions
DRUG	vehicle/placebo	vehicle/placebo

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2008-08-21
• Last updated: 2016-06-06

Locations

1 site across 1 country: United States