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

Study Overview
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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.

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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: Topical Vitamin D eye drop
* Drug: Topical placebo eye drop


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Prescribe topical placebo eye drop<br> | Drug: Topical placebo eye drop<br>* The same-shape packed drop without vitamin D<br>|
| Active Comparator: Prescribe topical Vitamin D eye drop<br> | Drug: Topical Vitamin D eye drop<br>* 25 Microgram/cc or 1000 IU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index score | The standard questionnaires. | 3 months | 

Secondary Outcome Measures

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