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Sponsored by: |
Novagali Pharma |
Information provided by: | Novagali Pharma |
ClinicalTrials.gov Identifier: | NCT00739349 |
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 |
ChemIDplus related topics: | Cyclosporine Cyclosporin |
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 |
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%
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Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
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2: Experimental
Cyclosporine 0.1%
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Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
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3: Placebo Comparator
Vehicle
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Drug: NOVA22007
Vehicle
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mourad AMRANE, MD | +33 (0)1 69 87 40 20 ext 22 | mourad.amrane@novagali.com |
United States, Maine | |||||
Central Maine Eye Care, PA | Recruiting | ||||
Lewiston, Maine, United States, 04240 | |||||
Contact: John D. LONSDALE, MD |
Novagali Pharma |
Responsible Party: | Novagali Pharma ( Mourad AMRANE, MD ) |
Study ID Numbers: | NVG08B112 |
First Received: | August 20, 2008 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00739349 |
Health Authority: | United States: Food and Drug Administration |
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