Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

Study Identifier
192371-024
CT.gov Identifier
NCT02013791
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Dry Eye
    • Study Drug
  • Vehicle
  • Cyclosporine New Ophthalmic Formulation
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Moderate to severe dry eye disease in both eyes * Best-corrected visual acuity (BCVA) of 20/100 or better in each eye
    Exclusion Criteria:
    * Use of any cyclosporine preparations within 3 months * 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

    Protocol Summary

    This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.

    Study Locations

    Location
    Status
    Location
    Sall Research Medical Center
    Artesia, California, United States, 90701
    Status
    Not applicable
    Location
    Lugene Eye Institute
    Glendale, California, United States, 91204
    Status
    Not applicable
    Location
    Lakeside Vision Center
    Irvine, California, United States, 92604
    Status
    Not applicable
    Location
    Steve Yoelin MD Medical Asscociates
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Wolstan & Goldberg Eye Associates
    Torrance, California, United States, 90505
    Status
    Not applicable
    Location
    Vision Institute
    Colorado Springs, Colorado, United States, 80907
    Status
    Not applicable
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