A Randomized, Multi-Center Trial of Topical Cyclosporin 0.05% in Steriod-Resistant Atopic Keratoconjunctivitis

Abstract

Abstract: : Purpose: We wanted to evaluate the efficacy and safety of topical cyclosporin A (CsA) 0.05% in the treatment of patients with severe, steroid resistant atopic keratoconjunctivitis (AKC) in a multi-center, placebo-controlled, double-masked, randomized trial. Methods: Twenty-two patients with AKC refractory to topical steroid treatment were randomly assigned (1:1) to treatment with topical 0.05% CsA eyedrops (Restasis, Allergan Inc) or placebo (artificial tears) for a period of 28 days: six times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Symptoms (itching, tearing, discomfort, mucous discharge and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis and blepharitis) of AKC were recorded on the day of enrollment and at the end of the treatment period. Separate composite scores were computed by summing the severity grade over all five symptoms and six signs of AKC for each patient. Results: There was a greater improvement in CsA group compared to placebo at the end of the 4-week treatment period (p=0.048 and p=0.002, for symptoms and signs respectively). No adverse effects of the treatment with CsA 0.05% eyedrops were observed. Conclusion: Topical CsA 0.05% (Restasis) appears to be safe and has a beneficial effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

Keywords: cyclosporine • immunomodulation/immunoregulation • cytokines/chemokines