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

Phase 2

• Conditions: Meibomian Gland Dysfunction
• Interventions: Drug: Topical placebo eye drop; Drug: Topical Vitamin D eye drop

• Registration Number: NCT05495958
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-24
• Study Start: 2022-07-25
• Study First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10
• Primary Completion: 2022-10-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prescribe topical placebo eye drop	Topical placebo eye drop	-
Prescribe topical Vitamin D eye drop	Topical Vitamin D eye drop	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index score	3 months	The standard questionnaires.

Secondary Outcome Measures

Name	Time	Method
Tear breakup time (TBUT)	3 months	time between fluorescein staining of the cul de sac and appearing dry island on the cornea
schirmer1	3 months	Millimeter of the standard strip wetting by tear of the patient
Fluorescein staining test	3 months	The number of fluorescein stained points on the cornea \& conjunctiva based on Oxford classification score

Trial Locations

Locations (1)

Ophthalmic Research center; 🇮🇷 Tehran, Iran, Islamic Republic of