Efficacy and Safety Study of Cyclosporine 0.010% to Treat Atopic Keratoconjunctivitis
Completed · Phase 3 · Has a placebo group
Conditions studied: Atopic Conjunctivitis
In brief
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.
Key facts
- Study ID
- NCT00884585
- Run by
- Allergan
- People needed
- 176
- Starts
- 2009-05-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2012-11-05
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Bakersfield, California, United States
- Study site — Randwick, New South Wales, Australia
- Study site — Ottawa, Ontario, Canada
- Study site — Prague, Czechia
- Study site — Dijon, Burgundy, France
- Study site — Munich, Bavaria, Germany
- Study site — Bangalore, Karnataka, India
- Study site — Tel Aviv, Israel
- Study site — Rome, Italy
- Study site — Wellington, New Zealand
- Study site — Valladolid, Spain
- Study site — Newcastle upon Tyne, Tyne and Wear, United Kingdom
Full record on ClinicalTrials.gov
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