Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With MGD

Meibomian Gland Dysfunction Clinical Trial

Official title:

Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962386
• Other study ID #: ?2019-363
• Status: Recruiting
• Start date: March 6, 2019
• Est. completion date: March 6, 2022

Study information

• Verified date: June 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: jin x ming, phd
• Phone: 18757163724
• Email: 18757163724[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project aims to evaluate the possible relationship between MGD and HRT in perimenopausal women

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 6, 2022
• Est. primary completion date: March 6, 2022
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Perimenopausal women who did not undergo HRT

Exclusion Criteria:

• (1) Patients who meet any of the following criteria will not be eligible for inclusion in the study: ? Unable or unwilling to sign a consent form, or unable to follow study procedures. (2) 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.? is pregnant, nursing or breastfeeding, or has received HRT treatment. ? 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.

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Drug:
• Hormone replacement therapy
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.

Locations

Country	Name	City	State
China	Hangzhou Obstetrics and Gynecology Hospital	Hangzhou	Zhejiang
China	Second Affiliated Hospital of Zhejiang University Hospital	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months