A RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF TOPICAL CYCLOSPORINE-A IN STEROID-DEPENDENT ATOPIC KERATOCONJUNCTIVITIS

Objective: This study aimed to investigate the therapeutic effect of t opical cyclosporin A (CsA) 2% in maize oil as a steroid-sparing agent in steroid-dependent atopic keratoconjunctivitis. Design: Prospective, randomized, double-masked, placebo-controlled trial, Participants: Tw enty-one patients with steroid-dependent atopic keratoconjunctivitis w ere studied. Intervention: Patients used either topical CsA or vehicle four times daily for 3 months in addition to their usual therapy, and the clinical response was used to taper or stop topical steroids when possible. Main Outcome Measures: Steroid drop usage per week, ability to cease steroid use, scores for symptoms and clinical signs, drop si de effects, and overall subjective rating of trial drop by patients an d clinician were measured. Results: Cyclosporin A had a greater steroi d-sparing effect than did placebo. Nine of 12 CsA patients ceased ster oids compared to 1 of 9 placebo patients (P = 0.01), the final steroid use was lower in the CsA group (2.6 +/- 1.4 vs. 27.7 +/- 17.7, P = 0. 005), and the mean reduction in steroid use was greater for CsA (85.5 +/- 14.7 vs. 13.9 +/- 16.0, P = 0.005), Clinical signs and symptom sco res were reduced to a greater level for CsA. Serious side effects were lid skin maceration in one patient using CsA and an allergic reaction in one placebo patient. Marked blurring of vision after drop instilla tion was common in both groups, but intense stinging was more common i n CsA patients (9/12 vs. 1/9, P = 0.01), limiting frequency of drop us e. The clinician rated the trial drops as good or excellent more frequ ently for GsA (11/12 vs. 0/9, P < 0.0001). Conclusions: Topical CsA is an effective and safe steroid-sparing agent in atopic keratoconjuncti vitis and, despite difficulties in patient tolerance, also improves sy mptoms and signs.