CompletedPhase 3

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

United States, Australia, Canada176 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Treatment Responders

Timeframe: Baseline, Month 2

Trial details

NCT IDNCT00884585

SponsorAllergan

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

Results submitted2012-09-27

View on ClinicalTrials.gov More Atopic Conjunctivitis trials