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

Santen SAS1 site in 1 country132 target enrollmentAugust 2008

ConditionsDry Eye

InterventionsNOVA22007 ''Cyclosporine''vehicle/placebo

DrugsNOVA22007 ''Cyclosporine''vehicle/placebo

Overview

Phase: Phase 2
Intervention: NOVA22007 ''Cyclosporine''
Conditions: Dry Eye
Sponsor: Santen SAS
Enrollment: 132
Locations: 1
Primary Endpoint: Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

January 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Santen SAS

Responsible Party

Sponsor

Eligibility 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