A randomized trial of low-dose, topical mitomycin-C in the treatment of severe vernal keratoconjunctivitis

Objective: To evaluate the efficacy and safety of low-dose, topical mitomycin-C in patients with severe vernal keratoconjunctivitis. Design: Placebo-controlled, double-masked, randomized clinical trial. Participants: Twenty-six patients with vernal keratoconjunctivitis refractory to combination of steroid and mast-cell stabilizer treatment. Intervention: Patients were randomly assigned (2:1) to treatment with topical 0.01% mitomycin-C eye drops (n = 17) or placebo (n = 9) three times daily for 2 weeks. Main Outcome Measures: Symptoms (itching, tearing, photophobia, ropy mucous discharge, foreign body sensation) and signs (conjunctival hyperemia, epithelial punctate keratitis, Trantas' dots, limbal edema, and palpebral conjunctival giant papillae) of vernal keratoconjunctivitis recorded on the day of enrollment and at the end of the treatment period. Results: There was a statistically significant decrease in ropy mucous discharge, photophobia, conjunctival hyperemia, and limbal edema in the mitomycin-C treated group compared with the placebo group at the end of the 2-week treatment period. In addition, none of the 17 treated patients, but all 9 of the placebo patients, required medication during the 4-week posttreatment follow-up period. No adverse effects of treatment with mitomycin-C were observed. Conclusions: Short-term, low-dose, topical mitomycin-C may be considered in the acute exacerbation periods of patients with severe vernal keratoconjunctivitis refractory to conventional treatment. (C) 2000 by the American Academy of Ophthalmology.