The Efficacy of 0.1% Tacrolimus Eye Drop for Noninfectious, Non-Necrotizing Anterior Scleritis
Abstract BACKGROUND: To examine the efficacy of 0.1% tacrolimus eye drops in the treatment of noninfectious, non-necrotizing anterior scleritis. METHODS: This prospective, single-arm study included nine patients (4 males and 5 females; mean age = 59.4 years, standard deviation = 10.5) with anterior scleritis. All patients were first treated with steroids for 1 month and then switched to tacrolimus eye drops alone. We defined baseline as the initiation of steroid or tacrolimus eye drops. Hyperemia and pain were scored before each treatment, at 1 and 2 weeks, and at 1 month after initiation of each treatment by using 5 grades (0 = none; 1+ = mild; 2+ = moderate; 3+ = severe; 4+ = extremely severe). Intraocular pressure (IOP) was also measured from baseline to 6 months after initiating tacrolimus eye drops. Safety was assessed based on the severity and the incidence of adverse events. RESULTS: The scores of hyperemia and pain had significantly decreased from baseline by 1 week after initiating tacrolimus eye drops (both P < 0.05). No significant reduction was observed with steroid treatment throughout the 1-month period in terms of both scores. Tacrolimus eye drops elicited statistically significant differences in mean IOP over the course of treatment (P = 0.02). No additional medications were required to provide relief in any of the patients receiving tacrolimus treatment. No patient had infectious adverse events after initiation of tacrolimus treatment. CONCLUSIONS: Topical tacrolimus may effectively and immediately reduce clinical signs and symptoms of noninfectious, non-necrotizing anterior scleritis. TRIAL REGISTRATION: This trial was prospectively registered on 16/10/2015 under the number (UMIN000034460).