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

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ClinicalTrials.gov Identifier: NCT00739349
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Santen SAS

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: NOVA22007 ''Cyclosporine'' Drug: vehicle/placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Cyclosporine 0.05%
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
Experimental: 2
Cyclosporine 0.1%
Drug: NOVA22007 ''Cyclosporine''
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
Placebo Comparator: 3
vehicle/placebo
Drug: vehicle/placebo
vehicle/placebo



Primary Outcome Measures :
  1. Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions [ Time Frame: Approximately 13 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739349


Locations
United States, Maine
Central Maine Eye Care, PA
Lewiston, Maine, United States, 04240
Sponsors and Collaborators
Santen SAS

Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT00739349     History of Changes
Other Study ID Numbers: NVG08B112
First Posted: August 21, 2008    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2015

Keywords provided by Santen SAS:
Dry Eye
Cyclosporine

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors