Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
NCT ID: NCT02013791
Last Updated: 2018-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
55 participants
INTERVENTIONAL
2014-04-29
2017-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Sham
Sham administered to non-study eye as per protocol on Day 1
Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 6C
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Stage 1 Cohort 6D
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.
Vehicle
Vehicle of cyclosporine administered as per protocol
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Interventions
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Vehicle
Vehicle of cyclosporine administered as per protocol
Sham
Sham administered to non-study eye as per protocol on Day 1
Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
Exclusion Criteria
* Use of topical medications, other than artificial tears, in the eyes within 1 month
* Use of contact lenses in either eye within 1 month
* Stage 2 only: Participation in Stage 1 of this study
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Eleonora Safyan
Role: STUDY_DIRECTOR
Allergan
Locations
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Sall Research Medical Center
Artesia, California, United States
Lugene Eye Institute
Glendale, California, United States
Lakeside Vision Center
Irvine, California, United States
Steve Yoelin MD Medical Asscociates
Newport Beach, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Johns Hopkins University - Wilmer Eye Institute
Baltimore, Maryland, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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More Information
Other Identifiers
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192371-024
Identifier Type: -
Identifier Source: org_study_id
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