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

Allergan

Status and phase: Completed; Phase 3

Conditions: Atopic Conjunctivitis

Treatments: Drug: Cyclosporine 0.010%; Drug: Cyclosporine Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00884585

192371-016

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

176 participants in 2 patient groups

Cyclosporine Ophthalmic Solution (COS) followed by COS

Experimental group

Description:

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.

Treatment:

Drug: Cyclosporine 0.010%

Placebo followed by COS

Other group

Description:

Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.

Treatment:

Drug: Cyclosporine Vehicle

Drug: Cyclosporine 0.010%