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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:
ClinicalTrials.gov Identifier:
NCT00739349
First Posted: August 21, 2008
Last Update Posted: June 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santen SAS
August 20, 2008
August 21, 2008
June 6, 2016
August 2008
January 2009   (Final data collection date for primary outcome measure)
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions [ Time Frame: Approximately 13 weeks ]
Same as current
Complete list of historical versions of study NCT00739349 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
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 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Dry Eye
  • Drug: NOVA22007 ''Cyclosporine''
    Cyclosporine 0.05% Ophthalmic Cationic Emulsions
  • Drug: NOVA22007 ''Cyclosporine''
    Cyclosporine 0.1% Ophthalmic Cationic Emulsions
  • Drug: vehicle/placebo
    vehicle/placebo
  • Experimental: 1
    Cyclosporine 0.05%
    Intervention: Drug: NOVA22007 ''Cyclosporine''
  • Experimental: 2
    Cyclosporine 0.1%
    Intervention: Drug: NOVA22007 ''Cyclosporine''
  • Placebo Comparator: 3
    vehicle/placebo
    Intervention: Drug: vehicle/placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
January 2009
January 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00739349
NVG08B112
Yes
Not Provided
Not Provided
Santen SAS
Santen SAS
Not Provided
Not Provided
Santen SAS
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP