Safety and efficacy of topical tacrolimus 0.03% in the management of vernal keratoconjunctivitis: a non-randomized controlled clinical trial.

Background: Vernal keratoconjunctivitis (VKC) is a bilateral, recurrent, chronic conjunctival inflammatory disease with seasonal exacerbations. This study aimed to assess the efficacy and safety of tacrolimus 0.03% eye ointment in the management of chronic VKC. Methods: This was an open-label, prospective, non-randomized, comparative interventional study that enrolled 50 patients with chronic VKC, who were allocated to one of two groups. The first group was treated with tacrolimus 0.03% eye ointment twice daily for 2 months then once daily for 2 months, followed by once every other day for another 2 months. The control group was treated with standard anti-allergic drugs, topical fluorometholone 0.1% eye drops three times daily for 2 weeks and gradually tapered for another 2 weeks, with topical olopatadine 0.1% administered twice daily during the follow-up period. Disease severity was assessed using a four-point scale for symptoms and signs. Treatment efficacy was assessed by analyzing changes in symptoms and signs, and by clinical photography. Results: Fifty patients with bilateral chronic VKC completed the follow-up. The mean (standard deviation) ages of the tacrolimus and control groups were comparable (16.20 [5.10] years versus 16.48 [4.19] years, Conclusions: Treatment of chronic bilateral VKC with tacrolimus 0.03% eye ointment is effective and safe. It could be considered an alternative treatment to reduce steroid-associated complications in patients with chronic VKC. Future double-blinded clinical trials with a longer follow-up period are necessary to confirm our findings and to determine the long-term safety of topical tacrolimus 0.03% ointment in VKC.