PURPOSE: To report the results of treating children with vernal keratoconjunctivitis (VKC) using a monotherapy of topical tacrolimus 0.03%. METHODS: This was a prospective, nonrandomized observational study of children newly diagnosed with VKC. The severity of the disease was graded on a 4-point scale of symptoms and signs. Patients were treated with tacrolimus 0.03% ointment and were followed for 8 months according to a schedule based on the severity of the disease. The primary measure of treatment efficacy was the change in the score of objective signs. The incidence and severity of adverse events, if any, were recorded. RESULTS: A total of 45 children aged 5-15 years were enrolled. The mean composite symptom score was 6.84 ± 2.26 at baseline and 0.71 ± 1.62 at 8 months, a statistically significant reduction (P < 0.001). The mean composite sign score was 9.6 ± 3.14 at baseline and 1.16 ± 1.28 at 8 months, also a statistically significant reduction (P < 0.001). Four patients had to be started on steroids within the first month of treatment and were considered treatment failures. Thus, 89% of patients showed significant improvement. No participant experienced adverse effects, although some reported a transient stinging sensation. CONCLUSIONS: In our study cohort topical tacrolimus ointment 0.03% as a monotherapy for VKC was successful in the majority of subjects, and there was no adverse effect.
PURPOSE: To report the results of treating children with vernal keratoconjunctivitis (VKC) using a monotherapy of topical tacrolimus 0.03%. METHODS: This was a prospective, nonrandomized observational study of children newly diagnosed with VKC. The severity of the disease was graded on a 4-point scale of symptoms and signs. Patients were treated with tacrolimus 0.03% ointment and were followed for 8 months according to a schedule based on the severity of the disease. The primary measure of treatment efficacy was the change in the score of objective signs. The incidence and severity of adverse events, if any, were recorded. RESULTS: A total of 45 children aged 5-15 years were enrolled. The mean composite symptom score was 6.84 ± 2.26 at baseline and 0.71 ± 1.62 at 8 months, a statistically significant reduction (P < 0.001). The mean composite sign score was 9.6 ± 3.14 at baseline and 1.16 ± 1.28 at 8 months, also a statistically significant reduction (P < 0.001). Four patients had to be started on steroids within the first month of treatment and were considered treatment failures. Thus, 89% of patients showed significant improvement. No participant experienced adverse effects, although some reported a transient stinging sensation. CONCLUSIONS: In our study cohort topical tacrolimus ointment 0.03% as a monotherapy for VKC was successful in the majority of subjects, and there was no adverse effect.