The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
NCT05495958 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2022-08-10
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
Interventions
- DRUG
-
Topical Vitamin D eye drop
25 Microgram/cc or 1000 IU
- DRUG
-
Topical placebo eye drop
The same-shape packed drop without vitamin D
Sponsors & Collaborators
-
Shahid Beheshti University of Medical Sciences
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-25
- Primary Completion
- 2022-10-30
- Completion
- 2022-12-30
Countries
- Iran
Study Locations
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