Treatment of vernal keratoconjunctivitis a double-masked study.

Thirty-one children aged five to 14 years with severe vernal keratoconjunctivitis (VKC) were enrolled in a double-masked study evaluating the efficacy of three ophthalmic preparations: cromolyn sodium (Opticrom) 2%, artificial tears and fluorometholone 0.1% (FML). These drugs were coded respectively as A, B, C, and dispensed in similar bottles. Both eyes were treated, and drug assignment was made at random. Objective assessment of the disease activity was done under slit lamp by two ophthalmologists according to a five-point scale. The results were tabulated and the chi-square test performed. Decoding of the drugs was done only after completion of the statistical analysis. FML was found effective with a statistically significant difference from the other two drugs, both after the first week on the initially assigned treatment (p = 0.05) and on completion of the treatment period according to protocol (p = 0.005). Although several patients improved under cromolyn sodium, there was no statistically significant difference between cromolyn sodium 2% and artificial tears. All the preparations were well tolerated. One patient developed bilateral allergic blepharitis when treated with FML during the study. Another patient who responded well to FML developed posterior subcapsular cataract while continuing treatment with corticosteroids a few months after completion of the study.