Therapeutic effects of 0.1% tacrolimus eye drops for refractory allergic ocular diseases with proliferative lesion or corneal involvement

Abstract

Background: The objective of this study was to investigate the efficacy of topical 0.1% tacrolimus in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement.

Methods: This prospective observational study included 1436 patients with refractory allergic conjunctivitis whose condition had responded poorly to conventional antiallergic drugs and/or topical steroids and/or topical cyclosporine. All patients received tacrolimus eye drops twice daily during the study period. Ten clinical signs and six clinical symptoms were rated on a four-grade scale. The primary endpoint was the change from baseline in total clinical signs and symptoms score at the last observation or following 6 months of treatment.

Results: Total signs and symptoms score significantly decreased after 1 month of treatment (p<0.001). Giant papillae and corneal lesions were also reduced by tacrolimus eye drop use (p<0.001). The drug proved effective in patients whose condition did not respond well to topical cyclosporine therapy. About 50% of all patients using topical steroids were weaned. The most common adverse reaction was a transient burning sensation (3.20%).

Conclusions: Tacrolimus eye drops are highly effective in treating refractory allergic conjunctivitis with proliferative lesions and/or corneal involvement, and may reduce or replace topical steroid use.

Trial registration number: UMIN 000008640.

Keywords: Conjunctiva; Drugs; Immunology; Inflammation; Treatment Medical.

Figure 1

Change from baseline in total symptom and sign scores during the 6-month study period (n=1436 patients). Error bars represent 1 SD. The statistical significance of each score change was evaluated using the Wilcoxon signed rank test.

Figure 2

Distribution of giant papillae (A) and corneal involvement (B) scores. The statistical significance of each score change from baseline was evaluated using the Wilcoxon signed rank test.

Figure 3

Changes from baseline in total sign and symptom scores in patients who did not respond well to prior cyclosporine ophthalmic solution therapy. Error bars represent 1 SD. The statistical significance of each score change was evaluated using the Wilcoxon signed rank test.

Figure 4

Proportions of patients using topical steroids at baseline and throughout the 6-month period during which the patients received topical tacrolimus eye drops.