Treatment of refractory dry eye associated with graft versus host disease with 0.03% tacrolimus eyedrops.

PURPOSE: We investigate the efficacy of 0.03% topical tacrolimus eyedrops for the treatment of dry eye in graft versus host disease (GVHD) patients resistant/intolerant to 0.05% topical cyclosporine.

METHODS: Forty-three patients were enrolled in this prospective study. After completing a 1-year run-in period of using artificial tears, 50% autologous serum eyedrops, and punctal plug occlusion, all the symptomatic patients (n=29) were treated with 0.05% topical cyclosporine (Restasis(®); Allergan, Inc.). After 1 month, the patients who presented topical or systemic intolerance to cyclosporine were instructed to instill 0.03% topical tacrolimus once a day for 3 months (n=14). All the patients were allowed to continue with their basal dry eye treatment. Visual acuity, fluorescein staining, Schirmer test, fluorescein tear break-up time, and tear meniscus height measurement were evaluated fortnightly (minimum 3 months). Subjective assessments of symptoms were also reported at the beginning and at the end of the study.

RESULTS: Dry eye symptoms and signs improved statistically (P<0.05) and significantly with tacrolimus and cyclosporine topical treatment. No significant differences were observed between both the groups. The mean follow-up time was 12.14±2.69 months (range 10-18 months).

CONCLUSION: The findings of this prospective pilot study suggest that cyclosporine-intolerant patients with dry eye associated with GVHD can be effectively treated with topical tacrolimus.