A double-masked comparison of 0.1% tacrolimus ointment and 2% cyclosporine eye drops in the treatment of vernal keratoconjunctivitis in children.

OBJECTIVE: To compare the efficacy of 0.1% tacrolimus (FK-506) ophthalmic ointment with 2% cyclosporine eye drops in the treatment of vernal keratoconjunctivitis (VKC).

DESIGN: Prospective double-masked randomized comparative trial.

PARTICIPANTS: Twenty-four VKC patients were enrolled into the study. Their mean age was 9.61 +/- 2.55 years. Twelve patients were allocated into the FK-506 group and the other twelve into the cyclosporine group. Their baseline characteristics were similar between groups.

METHODS: After a 2 week run-in period, patients were randomized into 2 groups in a double-masked, parallel fashion. Group A received 0.1% FK-506 eye ointment twice daily with placebo eye drops four times daily for 8 weeks. Group B received 2% cyclosporine eye drops with placebo ointment for the same duration. All patients received an open-treatment with 0.1% FK-506 eye ointment for another 4 weeks. Subjective ocular symptoms and side effects were recorded by patients once daily, during the entire period. Objective ocular signs were evaluated and scored at each follow up visit.

MAIN OUTCOME MEASURE: Improvement of total subjective symptom scores per day (TSSS) within group and between groups at various time points.

RESULTS: For within group comparison, there was a significant decrease in TSSS, compared to their baselines, at weeks 4 and 8, in both treatment groups. However, no statistical difference in TSSS was noted between groups at any time point. Total ocular sign scores (TOSS) in the FK-506 group decreased significantly at weeks 4 and 8 compared to baseline. Although there was a decrease of TOSS in the cyclosporine group, the difference did not reach statistical significance. Side effect scores reduced significantly in both groups at week 4 compared to their respective baselines (p = 0.034 in the FK506 group and p = 0.003 in the cyclosporine group). There was no significant difference in the comparison between groups on TOSS and side effect scores at any time point of the study. During the open FK-506 period, patients in cyclosporine group showed further reduction of both TSSS and TOSS. However, these changes were not statistically significant (p > 0.05).

CONCLUSION: 0.1% FK-506 eye ointment and 2% cyclosporine were both effective in treatment of VKC. 0.1% FK-506 could become another viable therapeutic option for VKC.