Evaluation of topical cromolyn sodium in the treatment of vernal keratoconjunctivitis.

A randomized, double-masked, placebo-controlled multicenter study was conducted for 6 weeks in 12 centers to evaluate the efficacy and safety of cromolyn sodium 4% ophthalmic solution (Opticrom) for the treatment of active bilateral vernal conjunctivitis. Objective clinical signs were graded weekly by an ophthalmologist while patients kept a daily record of the severity of their symptoms. Sixty-five patients completed the study; 35 received cromolyn sodium and 30 were treated with a matching placebo (the drug vehicle). Statistically significant differences in favor of cromolyn sodium treatment were found for conjunctival injection, limbal injection, limbal edema, tearing, and symptoms summary score. There were few side effects (usually mild stinging and burning which did not require drug stoppage). Only one patient required drug discontinuation for possible drug- or vehicle-related side effects. Cromolyn sodium was found to be significantly more effective than placebo in treating the signs and symptoms of vernal keratoconjunctivitis (VKC). When results were stratified in terms of the atopic status of the patient, it was clear that the allergic patients responded better to cromolyn sodium than did those in whom allergic (IgE-mediated) factors appeared unimportant in the disease process.