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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05495958
• Other study ID #: 14014
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 25, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• Topical Vitamin D eye drop
25 Microgram/cc or 1000 IU
• Topical placebo eye drop
The same-shape packed drop without vitamin D

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Surface Disease Index score	The standard questionnaires.	3 months
Secondary	Tear breakup time (TBUT)	time between fluorescein staining of the cul de sac and appearing dry island on the cornea	3 months
Secondary	schirmer1	Millimeter of the standard strip wetting by tear of the patient	3 months
Secondary	Fluorescein staining test	The number of fluorescein stained points on the cornea & conjunctiva based on Oxford classification score	3 months