Topical 2% cyclosporine A in preservative-free artificial tears for the treatment of vernal keratoconjunctivitis.

BACKGROUND

A double-masked, placebo-controlled trial to evaluate the short-term efficacy and safety of topical 2% cyclosporine A in preservative-free artificial tears for patients with vernal keratoconjunctivitis.

METHODS

Twenty patients with severe vernal keratoconjunctivitis were included in the study. All were treated with topical 2% cyclosporine A eye drops. One eye of each patient was administered 2% cyclosporine A in preservative-free artificial tears; the fellow eye received the placebo (vehicle) for the first 2 weeks, in a double-masked, placebo-controlled trial. Thereafter, the placebo eye received cyclosporine A (open trial). Symptoms and signs were scored on the day of enrollment and at the end of week 2, 4, and 14.

RESULTS

At the end of week 2, no statistically significant decrease was noted from baseline in mean scores of either signs (p = 0.18) or symptoms (p = 0.50) in the eyes that received placebo. On the other hand, a statistically significant decrease was observed in both sign and symptom scores (p < 0.001, for both) of eyes that received cyclosporine A. Significant differences were also noted at 2 weeks in mean scores of both signs and symptoms (p < 0.001, for both) between the eyes that received cyclosporine A and those that received placebo. At week 4 and 14, statistically significant decreases in both sign scores and symptom scores were noted compared with baseline in the eyes that received cyclosporine A and in the eyes that had initially received placebo (p < 0.001, for all).

INTERPRETATION

Topical 2% cyclosporine A in preservative-free artificial tears is effective in alleviating signs and symptoms of patients with severe vernal keratoconjunctivitis and had no observed side effects over the course of the study.