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NCT00739349 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00739349
Other study ID # NVG08B112
Secondary ID
Status Completed
Phase Phase 2
First received August 20, 2008
Last updated June 15, 2015
Start date August 2008
Est. completion date January 2009

Study information
Verified date June 2015
Source Novagali Pharma
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
• NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
• NOVA22007
Vehicle

Locations
Country Name City State
United States Central Maine Eye Care, PA Lewiston Maine

Sponsors (1)
Lead Sponsor Collaborator
Novagali Pharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions Approximately 13 weeks Yes
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