NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye - Full Text View

Sponsored by:	Novagali Pharma
Information provided by:	Novagali Pharma
ClinicalTrials.gov Identifier:	NCT00739349

Purpose

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.

Condition	Intervention	Phase
Dry Eye	Drug: NOVA22007 ''Cyclosporine'' Drug: NOVA22007	Phase II

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Novagali Pharma:

Primary Outcome Measures:

Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions [ Time Frame: Approximately 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	129
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cyclosporine 0.05%	Drug: NOVA22007 ''Cyclosporine'' Cyclosporine 0.05% Ophthalmic Cationic Emulsions
2: Experimental Cyclosporine 0.1%	Drug: NOVA22007 ''Cyclosporine'' Cyclosporine 0.1% Ophthalmic Cationic Emulsions
3: Placebo Comparator Vehicle	Drug: NOVA22007 Vehicle

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739349

Locations

United States, Maine
Central Maine Eye Care, PA
Lewiston, Maine, United States, 04240

Sponsors and Collaborators

Novagali Pharma

More Information

Responsible Party:	Novagali Pharma ( Mourad AMRANE, MD )
Study ID Numbers:	NVG08B112
Study First Received:	August 20, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00739349
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novagali Pharma:

Dry Eye
Cyclosporine

Study placed in the following topic categories:

Signs and Symptoms
Cyclosporine
Clotrimazole

Miconazole
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009