Meibomian Gland DysfunctionNCT04962386
Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD
An observational study of Meibomian Gland Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Hormone replacement therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 6 Mar 2019to 6 Mar 2022
- Phase
- Observational
- 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 25 to 45 years
- Women only
- Adult
Study population: MGD is a relatively new field of research in ophthalmology, so it has not been extensively studied up to now. However, MGD is believed to be a major cause of DE disease worldwide. It is estimated that MGD accounts for more than two-thirds of all DE cases. In one study, MGD accounted for 78 % of DE patients. The estimated incidence of MGD in Asian adults over 40 years of age ranges from 46.2% to 69.3%. Previous studies have shown that the production and stability of tears in postmenopausal women are reduced, and hormone replacement therapy can restore SLT values to the normal range. However, some studies have reported that women who receive HRT have a higher mortality rate than women who do not.
Who may be able to join
- Perimenopausal women who did not undergo HRT
Who cannot join
- (1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.
- Have worn contact lenses in the past month, have had anterior segment surgery in the past 3 months, have a history of corneal refractive surgery, and have eye diseases other than dry eyes.Use of topical medicines other than eye lubricants in the past 3 months.Use of total body immunomodulators, tetracycline, or glucocorticoids in the past 3 months.Occlusion of lacrimal dots or eye trauma in the past 3 months.③ is pregnant, nursing or breastfeeding, or has received HRT treatment.
- ④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Hangzhou Obstetrics and Gynecology Hospital
Hangzhou, Zhejiang, 350051
yuan k lan, phd, 18345193567, yankeyuankelan@126.com
- Recruiting
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou
qin qi yu, 18757163724, 18757163724@163.com
About this study
Official title: Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women
Read the detailed description
This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Hormone replacement therapy
- 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.
Hormone replacement therapyDrug
Also called Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)
HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Perimenopausal women who did not undergo HRT | Perimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs Receives: Drug: Hormone replacement therapy | |
| Perimenopausal women who did undergo HRT | Perimenopausal women who did undergo HRT received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV. Weesp, The Netherlands).Take this medicine once a day. A course of treatment was defined as 28 days of continuous treatment. Receives: Drug: Hormone replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear secretion
After local anesthesia, a 35mm×5mm filter paper strip was placed longitudinally into the conjunctival sac of the lower eyelid. After 5 minutes, the length of the moist part was recorded. Less than 10mm was considered abnormal.
Measured: 3 months
Secondary outcomes (2)
Noninvasive tear break-up time test (NITBUT)
After fluorescein staining, patients were asked to close their eyes and measure the time until the first tear film break point appeared.The average of the three measurements was recorded and was considered abnormal for less than 10 seconds.
Measured: 3 months
The scoring of corneal fluorescein staining
The cornea was divided into two groups on average. After staining, the upper, middle and lower corneal sites were recorded and the scores of each site were recorded.0= no punctate staining;1= less than half staining: 2= more than half staining;3= total staining;And the cumulative score (0-9 points) for each quadrant.CFS was assessed at each follow-up.
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 posted15 Jul 2021
- Study start6 Mar 2019
- Primary completion6 Mar 2022 (estimated)
- Study completion6 Mar 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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin x ming, phd, Study director, Second Affiliated Hospital of Zhejiang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962386
- Sponsor's protocol ID
- 研2019-363
- Status last verified
- Jun 2021
- First submitted
- 4 Jul 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04962386
- Acronym / sponsor ID
- 研2019-363
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 6 Mar 2022 (estimated)
- Study completion
- 6 Mar 2022 (estimated)
- First posted
- 15 Jul 2021 (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.
This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women
Detailed description
This project aims to: 1. Evaluate the possible relationship between MGD and HRT in perimenopausal women; 2. To explore the mechanism of HRT treatment on MGD through clinical trials;3. Optimize treatment methods by exploring the mechanism, and develop more personalized and systematic treatment plans for MDG patients in the perimenopausal period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perimenopausal women who did not undergo HRT | – | Drug: Hormone replacement therapyPerimenopausal women who did not undergo HRT at baseline. And they did not receive any other drugs |
| Perimenopausal women who did undergo HRT | – | Drug: Hormone replacement therapyPerimenopausal women who did undergo HRT received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV. Weesp, The Netherlands).Take this medicine once a day. A course of treatment was defined as 28 days of continuous treatment. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- MGD is a relatively new field of research in ophthalmology, so it has not been extensively studied up to now. However, MGD is believed to be a major cause of DE disease worldwide. It is estimated that MGD accounts for more than two-thirds of all DE cases. In one study, MGD accounted for 78 % of DE patients. The estimated incidence of MGD in Asian adults over 40 years of age ranges from 46.2% to 69.3%. Previous studies have shown that the production and stability of tears in postmenopausal women are reduced, and hormone replacement therapy can restore SLT values to the normal range. However, some studies have reported that women who receive HRT have a higher mortality rate than women who do not.
Key inclusion criteria (1 listed)
- Perimenopausal women who did not undergo HRT
Key exclusion criteria (3 listed)
- (1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ① Unable or unwilling to sign a consent form, or unable to follow study procedures.
- ④ All patients with DE related diseases, such as diabetes mellitus, Sjogren syndrome, Stevens-Johnson syndrome.All participants were free of cancer, liver disease, kidney disease, stroke, transient cerebral ischemia, myocardial infarction, peptic ulcer, gout, or mental illness.Women who used anticoagulants, corticosteroids or vitamin A, vitamin E or beta-carotene were also excluded.
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 |
|---|---|---|
| Hormone replacement therapyAlso: Received estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, The Netherlands)HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days. | Drug | Perimenopausal women who did not undergo HRT, Perimenopausal women who did undergo HRT |
Primary outcome
Tear secretion
Time frame: 3 months
After local anesthesia, a 35mm×5mm filter paper strip was placed longitudinally into the conjunctival sac of the lower eyelid. After 5 minutes, the length of the moist part was recorded. Less than 10mm was considered abnormal.
2 secondary outcomes
Noninvasive tear break-up time test (NITBUT)
Time frame: 3 months
The scoring of corneal fluorescein staining
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 13 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Jin x ming, phd study director
Second Affiliated Hospital of Zhejiang University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Gland Dysfunction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
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 3 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 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact jin x ming, phd (18757163724, 18757163724@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear secretion (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 13 Sep 2021.