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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):
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT00739349
First received: August 20, 2008
Last updated: May 26, 2016
Last verified: June 2015

August 20, 2008
May 26, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739349 on ClinicalTrials.gov Archive Site
Not Provided
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
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
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Novagali Pharma
Novagali Pharma
Not Provided
Not Provided
Novagali Pharma
June 2015

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