Back to resultsNOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
NOVA22007 ''Cyclosporine''
NOVA22007 ''Cyclosporine''
vehicle/placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Dry Eye, Cyclosporine
Eligibility 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
Sites / Locations
- Central Maine Eye Care, PA
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Cyclosporine 0.05%
Cyclosporine 0.1%
vehicle/placebo
Outcomes
Primary Outcome Measures
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00739349
Brief Title
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen SAS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Dry Eye, Cyclosporine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Cyclosporine 0.05%
Arm Title
2
Arm Type
Experimental
Arm Description
Cyclosporine 0.1%
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
vehicle/placebo
Intervention Type
Drug
Intervention Name(s)
NOVA22007 ''Cyclosporine''
Intervention Description
Cyclosporine 0.05% Ophthalmic Cationic Emulsions
Intervention Type
Drug
Intervention Name(s)
NOVA22007 ''Cyclosporine''
Intervention Description
Cyclosporine 0.1% Ophthalmic Cationic Emulsions
Intervention Type
Drug
Intervention Name(s)
vehicle/placebo
Intervention Description
vehicle/placebo
Primary Outcome Measure Information:
Title
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions
Time Frame
Approximately 13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Central Maine Eye Care, PA
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
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