At a glance
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Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
In Brief
A Phase 3 clinical trial evaluating Cyclosporine Vehicle and Cyclosporine 0.010% for Atopic Conjunctivitis. Completed, enrolled 176 participants across 12 sites in 12 countries.
Detailed 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 Details
Timeline
Interventions
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.