To evaluate the efficacy of 0.1% Tacrolimus eye drops in the treatment of dry eye (DE) caused by chronic graft-versus-host disease (cGVHD-DE) and compare it with the treatment of lubricating eye drops.

Prospective clinical study. The chronic graft-versus-host disease (cGVHD) patients with DE from the First Affiliated Hospital, Zhejiang University School of Medicine were included according to the inclusion criteria and categorized randomly into two different groups, Tacrolimus group (TAC) and sodium hyaluronate group (SH). Data were collected at the baseline, 2 weeks and 2 months after the treatments on patients' age, gender, primary diagnosis, time of onset, visual acuity (VA), ocular surface disease index (OSDI), corneal fluorescein staining (FL) and Schirm Ⅰ test (SⅠt). Other four objective DE indicators, including the height of tear meniscus (TMH), the first non-invasive tear break-up time (NIBUTf), the degree of conjunctival injection and the infrared meibography were also obtained and recorded by Keratograph 5M. Data were analyzed by variance analysis, Firedman andt-test, etc.

A total of 21 patients with 42 eyes were included, 11 patients (22 eyes) in the TAC, 10 patients (20 eyes) in SH. There was no significant difference in age, gender, and all clinical indicators at the baseline between the two groups. 2 weeks after the treatments, in TAC group, OSDI score (t=3.99, P=0.003), NIBUTf in both eyes (right eye: t=2.30, P=0.044; left eye: t=2.42, P=0.034) were significantly improved when compared with the baseline, in SH group, the indicators were OSDI score (t=3.20, P=0.011) and NIBUTf in right eyes (t=2.46, P=0.036) that had significant improvement. After 2 months of treatment, all clinical dry eye indicators in the TAC group were significantly improved compared with the baseline (P<0.05). But in the SH group, the SⅠt and the infrared meibography had no statistically significant difference when compared with the baseline. Comparing the two groups after 2 months of treatment, we found that all indicators in the TAC group were more significantly improved than that in the SH group, except for the FL, in which the difference had no statistical significance (P<0.05). No adverse ocular effect was found in the study in both groups.

0.1% tacrolimus eye drops are safe and effective in the treatment of cGVHD-DE, and Keratograph 5M is helpful in the evaluation and follow-up of the treatments.

chronic graft-versus-host disease; xerophthalmia; tacrolimus; sodium hyaluronate; Keratograph 5M