NCT05495958

The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub. The primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility. The grader and the patients will blind to the study group.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	Topical Vitamin D eye drop	25 Microgram/cc or 1000 IU
DRUG	Topical placebo eye drop	The same-shape packed drop without vitamin D

Timeline

• Start date: 2022-07-25
• Primary completion: 2022-10-30
• Completion: 2022-12-30
• First posted: 2022-08-10
• Last updated: 2022-08-10

Locations

1 site across 1 country: Iran