Tacrolimus in Corticosteroid-Refractory Vernal Keratoconjunctivitis.

PURPOSE: To evaluate the efficacy of 0.03% tacrolimus in the treatment of corticosteroid-refractory vernal keratoconjunctivitis (VKC). METHODS: This open-label study enrolled 30 patients with VKC who were not responding to topical corticosteroid treatment for at least 4 weeks. All patients were treated with 0.03% tacrolimus eye ointment 3 times daily, 0.05% ketotifen eye drops twice daily, and preservative-free artificial tears. Symptoms (itching, redness, watering, discharge, burning, and photophobia) and signs (conjunctival injection, papillae, cobblestone papillae, limbal inflammation, or hypertrophy and corneal epithelial staining) were graded on a 4-point scale at enrolment, after 4 weeks, and at the end of treatment period, which was at 12 weeks. Composite scores for symptoms and signs were computed by summing individual scores. Treatment failure was denoted if additional treatment with corticosteroids were required. RESULTS: The composite scores for symptoms (10.8, 3.8, 3.4) and signs (8.7, 4.7, 4.0) in 23 patients showed a statistically significant (P < 0.05) improvement from baseline to the 4- and 12-week visits. Among the signs, upper tarsal papilla showed improvement only at 12 weeks, but the scores for giant cobblestone papillae did not reach statistically significant reduction even at 12 weeks. There was improvement in visual acuity at 12 weeks, although it was not statistically significant (P = 0.05). Treatment failure was recorded in 17% patients. The only adverse effect reported was transient stinging sensation lasting for a few days. CONCLUSIONS: Tacrolimus 0.03% was apparently safe and effective in treating patients with steroid-refractory VKC. A small subset of patients may still require supplemental topical corticosteroids for resolution of their symptoms.