Comparision of efficacy and safety of 0.03% and 0.1% tacrolimus ointment in children with vernal keratoconjunctivitis.

Background: Topical immunosuppressants such as tacrolimus in different concentrations are a breakthrough in the management of recalcitrant vernal keratoconjunctivitis (VKC); however, there is a lacks of comparative studies to guide their use in VKC management.

Objective: To compare the efficacy and safety of tacrolimus 0.03% and 0.1% eye ointment in the treatment of recalcitrant VKC.

Design: A retrospective comparative single-centre observational study.

Method: We reviewed records of a total of 48 recalcitrant VKC patients treated with two different strengths of tacrolimus ointment between April 2016 and March 2017. Of these, 39 fulfilled the inclusion criteria and were categorized into two groups, A and B, depending on the use of strength of tacrolimus (0.03% and 0.1%) used, respectively. Group A had 18 patients, while group B had 21 patients. Thirty-six patients, 18 from each group, were finally analysed and compared. Records of patients were explored for the subjective symptoms and objective sign score of the patient at baseline and at each time point. The main outcome measures were composite scoring and comparison of total subjective symptom scores (TSSSs) and total objective sign scores (TOSSs) within and between the groups at each follow-up. Percentage of patient with significant reduction in symptom and sign scores as compared with baseline was considered success of treatment. Chi-square and t-tests were used for comparison of outcomes between both groups.

Results: Mixed variety was most commonly encountered type of VKC. The signs and symptoms were significantly reduced in patients with treatment in both groups (p = 0.001) in all types of VKC. However, in group B, there was significant improvement in the size of papillae (p = 0.04) as compared baseline in contrast to group A. Side effects like burning and stinging in group B were significantly higher as compared with group A.

Conclusions: Both strengths of tacrolimus (0.03% and 0.1%) are effective in all forms of recalcitrant VKC. Papillary component of VKC responds better with higher strength (0.1%) but is associated with more significant side effects. Different strengths of tacrolimus can be used strategically depending upon the severity and clinical type of VKC to intensify outcome and minimize side effects.