Safety and Efficacy of Topical Vitamin D in the Management of Dry Eye Disease Associated With Meibomian Gland Dysfunction: A Placebo-Controlled Double-Blind Randomized Controlled Trial.

Abstract

The aim of this study was to investigate the safety and efficacy of topical vitamin D in the management of dry eye disease associated with meibomian gland dysfunction (MGD). In this randomized controlled trial, patients with symptomatic MGD were divided into 2 groups to receive topical vitamin D drops or placebo in their randomized eyes. The exclusion criteria consisted of patients with vitamin D deficiency, previous ocular surgery, and patients with ocular diseases affecting the tear film. Patients and researchers were masked to the study groups. The outcomes included the score of Dry Eye Questionnaire (DEQ) 5 and Ocular Surface Disease Index (OSDI), corneal and conjunctival staining score, tear breakup time (TBUT), Schirmer, and MG expressibility score evaluated at baseline and weeks 4 and 8. Twenty-eight eyes of 28 patients were recruited in each group. In addition to the improvement of subjective parameters in both groups, there was a statistically significantly greater improvement in the vitamin D group compared with control for average scores of OSDI (13.38 ± 7.32 vs. 27.94 ± 7.49) and DEQ5 (9.67 ± 1.86 vs. 14.14 ± 2.45) at week 8 (Ps <0.001). In addition, a significant improvement in TBUT and Schirmer test was observed in both groups in weeks 4 and 8 ( P value <0.05). There was a significant difference between the treatment and control groups after 8 weeks for OSDI, DEQ5, Schirmer, TBUT, corneal fluorescein staining, and MG expressibility score ( P value <0.05). The preliminary results of this randomized controlled trial suggested that use of topical vitamin D drops with a lipid vehicle could be safe and might significantly improve the symptoms and signs of dry eye associated with MGD.