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

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05495958
Collaborator
(none)
56
1
2
5.2
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Topical Vitamin D eye drop
  • Drug: Topical placebo eye drop
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Actual Study Start Date :
Jul 25, 2022
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Prescribe topical placebo eye drop

Drug: Topical placebo eye drop
The same-shape packed drop without vitamin D

Active Comparator: Prescribe topical Vitamin D eye drop

Drug: Topical Vitamin D eye drop
25 Microgram/cc or 1000 IU

Outcome Measures

Primary Outcome Measures

  1. Ocular Surface Disease Index score [3 months]

    The standard questionnaires.

Secondary Outcome Measures

  1. Tear breakup time (TBUT) [3 months]

    time between fluorescein staining of the cul de sac and appearing dry island on the cornea

  2. schirmer1 [3 months]

    Millimeter of the standard strip wetting by tear of the patient

  3. Fluorescein staining test [3 months]

    The number of fluorescein stained points on the cornea & conjunctiva based on Oxford classification score

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthalmic Research center Tehran Iran, Islamic Republic of

Sponsors and Collaborators

  • Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zahra Rabbani Khah, Head of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT05495958
Other Study ID Numbers:
  • 14014
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022