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

Shahid Beheshti University of Medical Sciences

Status and phase

Active, not recruiting

Phase 3

Phase 2

Conditions

Meibomian Gland Dysfunction

Treatments

Drug: Topical placebo eye drop

Drug: Topical Vitamin D eye drop

Study type

Interventional

Funder types

Other

Identifiers

NCT05495958

14014

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.

Exclusion criteria

Patients with Vitamin D deficiency
Patients taking Vitamin D systemic Supplementation
Patient with prior ocular surgeries within previous 6 months.
Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease