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.