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

NCT ID: NCT05495958

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-25

Study Completion Date

2022-12-30

Brief Summary

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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

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Conditions

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Prescribe topical placebo eye drop

Group Type PLACEBO_COMPARATOR

Topical placebo eye drop

Intervention Type DRUG

The same-shape packed drop without vitamin D

Prescribe topical Vitamin D eye drop

Group Type ACTIVE_COMPARATOR

Topical Vitamin D eye drop

Intervention Type DRUG

25 Microgram/cc or 1000 IU

Interventions

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Topical Vitamin D eye drop

25 Microgram/cc or 1000 IU

Intervention Type DRUG

Topical placebo eye drop

The same-shape packed drop without vitamin D

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of Ophthalmic Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research center

Tehran, , Iran

Site Status

Countries

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Iran

Other Identifiers

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14014

Identifier Type: -

Identifier Source: org_study_id

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