Clinical Efficacy of Topical 0.1% Tacrolimus in Patients with Corneal Neovascularization: A Prospective, Multicenter, Randomized Controlled Pilot Trial

Purpose To evaluate the effect of topical 0.1% tacrolimus on corneal neovascularization (CoNV) and compare its efficacy with 1% prednisolone acetate. Methods In this prospective, multicenter, evaluator-masked, randomized study, patients with CoNV were randomized to 0.1% tacrolimus or 1% prednisolone acetate. Eye drops were administered four times daily for 4 weeks, then twice daily for an additional 4 weeks. Clinical assessments included CoNV grade, visual acuity, intraocular pressure, and ocular surface staining scores. A linear mixed model was used to evaluate treatment effects. Results Forty-six patients (tacrolimus group, n = 24; prednisolone group, n = 22) were analyzed. Most baseline characteristics were comparable between groups, except for endothelial cell density, which was significantly lower in the tacrolimus group (P = 0.040). In both groups, CoNV grade decreased significantly from baseline to week 4 (tacrolimus group: 2.025 ± 0.162 to 1.733 ± 0.162, P = 0.003; prednisolone group: 1.852 ± 0.168 to 1.625 ± 0.168, P = 0.035), with no significant between-group difference (P = 0.688). No significant change in CoNV grade was observed from week 4 to week 8 in either group. Over the 8-week period, significant within-group decrease in CoNV grade was observed in the tacrolimus group only (2.025 ± 0.162 to 1.697 ± 0.164, P = 0.019). Conclusion Both 0.1% tacrolimus and 1% prednisolone acetate reduced CoNV during the first 4 weeks. The sustained reduction in CoNV through 8 weeks in the tacrolimus group suggests its potential as an alternative or adjunctive therapy for CoNV, warranting further investigation.