NCT00884585

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Conjunctivitis

Interventions

Type	Name	Description
DRUG	Cyclosporine Vehicle	Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
DRUG	Cyclosporine 0.010%	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.

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-10-01
• Completion: 2011-07-01
• First posted: 2009-04-21
• Last updated: 2012-11-05
• Results posted: 2012-11-05

Locations

12 sites across 12 countries: United States, Australia, Canada, Czechia, France, Germany, India, Israel, Italy, New Zealand, Spain, United Kingdom