Meibomian Gland DysfunctionPhase 2/3NCT05495958
The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
A Phase 2/3 study testing Topical Vitamin D eye drop in people with Meibomian Gland Dysfunction, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Topical Vitamin D eye drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteIran
- Study dates
- 25 Jul 2022to 30 Dec 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Topical Vitamin D eye drop, Topical placebo eye drop
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Vitamin D eye dropDrug
25 Microgram/cc or 1000 IU
Topical placebo eye dropDrug
The same-shape packed drop without vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Prescribe topical placebo eye drop | Placebo comparator | Not described Receives: Drug: Topical placebo eye drop |
| Prescribe topical Vitamin D eye drop | Active comparator | Not described Receives: Drug: Topical Vitamin D eye drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index score
The standard questionnaires.
Measured: 3 months
Secondary outcomes (3)
Tear breakup time (TBUT)
time between fluorescein staining of the cul de sac and appearing dry island on the cornea
Measured: 3 months
schirmer1
Millimeter of the standard strip wetting by tear of the patient
Measured: 3 months
Fluorescein staining test
The number of fluorescein stained points on the cornea \& conjunctiva based on Oxford classification score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start25 Jul 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495958
- Sponsor's protocol ID
- 14014
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05495958
- Acronym / sponsor ID
- 14014
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Vitamin D eye drop25 Microgram/cc or 1000 IU | Drug | Prescribe topical Vitamin D eye drop |
| Topical placebo eye dropThe same-shape packed drop without vitamin D | Drug | Prescribe topical placebo eye drop |
Primary outcome
Ocular Surface Disease Index score
Time frame: 3 months
The standard questionnaires.
3 secondary outcomes
Tear breakup time (TBUT)
Time frame: 3 months
schirmer1
Time frame: 3 months
Fluorescein staining test
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Topical Vitamin D eye drop in people with Meibomian Gland Dysfunction, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.