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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Santen SAS
ClinicalTrials.gov Identifier:
NCT00739349
First received: August 20, 2008
Last updated: May 26, 2016
Last verified: June 2015
  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: vehicle/placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Santen SAS:

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 ]

Enrollment: 132
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Santen SAS
  More Information

Responsible Party: Santen SAS
ClinicalTrials.gov Identifier: NCT00739349     History of Changes
Other Study ID Numbers: NVG08B112
Study First Received: August 20, 2008
Last Updated: May 26, 2016

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

ClinicalTrials.gov processed this record on September 21, 2017