Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis

Study Identifier
192371-016
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Conjunctivitis
  • Study Drug
  • Cyclosporine Vehicle
  • Cyclosporine 0.010%
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12+ years

    Protocol Summary

    This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.

    Study Locations

    Location
    Status
    Location
    Bakersfield, California, United States
    Status
    Not applicable
    Location
    Randwick, New South Wales, Australia
    Status
    Not applicable
    Location
    Ottawa, Ontario, Canada
    Status
    Not applicable
    Location
    Prague, Czech Republic
    Status
    Not applicable
    Location
    Dijon, Burgundy, France
    Status
    Not applicable
    Location
    Munich, Bavaria, Germany
    Status
    Not applicable
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