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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)

• Be on stable doses of your current AKC medications for at least 2 weeks

Exclusion Criteria:

• You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study

• You are pregnant, breastfeeding, or planning to become pregnant during the study

• You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks