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
Study Drug
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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