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
Kiana Hassanpour1 , Farideh Langari1 , Amir Rezaeian Akbrzadeh2 , Mozhgan Rezaei Kanavi3 , Maryam Barani1 , Bahareh Kheiri1 , Farid Karimian1 , Hamid Ahmadieh1 , Mohammad-Mehdi Sadoughi1 *
- Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran;
- Tiam Pharm. Labs Company, Tehran, Iran;
- Ocular Tissue Engineering Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Abstract: This study aimed to investigate the safety and
efficacy of topical vitamin D in the management of dry eye disease
associated with meibomian gland dysfunction (MGD).
Methods: 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.
Results: 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 6 7.32 vs. 27.94 6 7.49) and
DEQ5 (9.67 6 1.86 vs. 14.14 6 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).
Conclusion: The preliminary results of this randomized con-
trolled trial suggested the use of topical vitamin D drops with a lipid
the vehicle could be safe and might significantly improve the symptoms
and signs of dry eye associated with MGD.
