Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
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.