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

NCT05495958 | Unknown Phase 2

• 1 other identifier: 14014
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index score

  The standard questionnaires.

  3 months

Secondary Outcomes (3)

• Tear breakup time (TBUT)

  3 months

• schirmer1

  3 months

• Fluorescein staining test

  3 months

Study Arms (2)

Prescribe topical placebo eye drop

PLACEBO COMPARATOR

Drug: Topical placebo eye drop

Prescribe topical Vitamin D eye drop

ACTIVE COMPARATOR

Drug: Topical Vitamin D eye drop

Interventions

Topical Vitamin D eye drop DRUG

25 Microgram/cc or 1000 IU

Prescribe topical Vitamin D eye drop

Topical placebo eye drop DRUG

The same-shape packed drop without vitamin D

Prescribe topical placebo eye drop

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research center

Tehran, Iran

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: July 24, 2022
• First Posted: August 10, 2022
• Study Start: July 25, 2022
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-07

Locations

IR (1)