Clinical safety and efficacy of vitamin D3 analog ointment for treatment of obstructive meibomian gland dysfunction.

BACKGROUND: Hyperkeratinization is a major cause of obstructive meibomian gland dysfunction (oMGD) and results in degenerative gland dilation and atrophy without inflammation. Ointment containing 1,25-dihydroxy-22-oxavitamin D3 (maxacalcitol), a noncalcemic analog of the active form of vitamin D3, is applied for the treatment of hyperkeratotic cutaneous conditions such as psoriasis and ichtyosis because it suppresses the proliferation and promotes the differentiation of keratinocytes through interaction with the vitamin D receptor. The aim of the present study was to evaluate the safety and efficacy of maxacalcitol ointment for the treatment of oMGD. METHODS: Six eyes of six healthy male subjects (mean age ± SD, 36.4 ± 10.8 years) and 12 eyes of eight oMGD patients (five men and three women; mean age ± SD, 55.6 ± 13.2 years) were enrolled in the study. Maxacalcitol ointment was applied to the upper and lower lid margins twice a day for 8 weeks. Subjective symptoms, lid margin abnormalities, tear film breakup time (BUT), ocular surface staining, meibum grade, Schirmer test value, and meibomian gland area were evaluated in the oMGD patients before, during, and after the treatment period. RESULTS: Severe adverse effects of ointment application were not observed in the healthy subjects or oMGD patients. The clinical scores for plugging of meibomian gland orifices and lid margin vascularity as well as BUT, meibum grade, and meibomian gland area were significantly improved in oMGD patients after the 8-week treatment period compared with pretreatment values (P values of <0.001, 0.020, 0.030, 0.020, and 0.017, respectively). CONCLUSIONS: Topical eyelid application of an analog of the active form of vitamin D3 was found to be safe as well as to improve the condition of patients with oMGD. Such ointment thus warrants further evaluation as a potential new treatment option for this condition. TRIAL REGISTRATION: This study was registered with the UMIN database (ID: UMIN000016230 ) on 16 January 2015.