NCT07633938

Brief Summary

This study aims to conduct a randomized controlled clinical trial to compare the efficacy of a new type of massage device - eyelid support plate and glass rod assisted eyelid massage in improving MGD related dry eye symptoms, and evaluate the comfort and efficiency of both treatments, providing evidence-based support for clinical work

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Jul 2026Sep 2027

First Submitted

Initial submission to the registry

June 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

June 2, 2026

Last Update Submit

June 8, 2026

Conditions

Dry Eye Disease (DED)MGD-Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in Ocular Surface Disease Index (OSDI) score at week 8

    The OSDI is a 12-item patient-reported outcomes questionnaire, which to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function.Each item is rated based on the frequency of symptoms in the past week: never (0 points) → sometimes (1 point) → half the time (2 points) → most of the time (3 points) → always (4 points),total score 0-100 points.The higher the score, the more obvious the dry eye symptoms.

    Baseline, week 4, week 8

Secondary Outcomes (2)

  • Change in first non-invasive tear film break time

    Baseline, week 4, week 8

  • proportion of Ocular Surface Disease Index (OSDI) scores showing a change ≥10 points from baseline at week 8

    Baseline, week 4, week 8

Other Outcomes (8)

  • change in non-invasive lacrimal height measurement(NITMH)

    Baseline, week 4, week 8

  • Change in meibomian gland absence status

    Baseline, week 4, week 8

  • Change in lipid layer thickness (LLT)

    Baseline, week 4, week 8

  • +5 more other outcomes

Study Arms (2)

glass rod group

EXPERIMENTAL

Implement glass rod assisted eyelid massage for a total of 4 times

Procedure: glass rod assisted eyelid massage

eyelid support plate group

EXPERIMENTAL

Implement eyelid support plate assisted eyelid massage for a total of 4 times.

Procedure: eyelid support plate assisted eyelid massage

Interventions

eyelid support plate assisted eyelid massagePROCEDURE

The participants of experimental group receive sodium hyaluronate eye drops in both eyes four times a day for 8 weeks, and receive eyelid support plate assisted eyelid massage based on the group standard of Meibomian gland massage procedure (T/GDPMAA003-2023) every two weeks for a total of four times. Follow up evaluations will be conducted at weeks 4 and 8.

eyelid support plate group
glass rod assisted eyelid massagePROCEDURE

The participants of control group receive sodium hyaluronate eye drops 4 times a day for 8 weeks, and receive glass rod assisted eyelid massage based on the group standard of "Meibomian gland massage operation procedure" (T/GDPMAA003-2023) every 2 weeks, for a total of 4 times. Follow up evaluations will be conducted at weeks 4 and 8

glass rod group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Voluntarily participate and sign an informed consent form;
  • Age range: 18 to 60 years old;
  • Meet the diagnostic criteria for dry eye in the International Society of Tears and Ocular Surface (TFOS) Dry Eye Symposium (DEWS) II ;
  • /3 or more of the meibomian gland openings are blocked or the secretion characteristics of the meibomian gland are abnormal;
  • The best corrected visual acuity for each eye is ≥ 0.5;
  • Eye pressure (IOP) ≥ 5mmHg and ≤ 21mmHg per eye;
  • Women with reproductive potential agree to use reliable contraceptive methods during the study period;
  • Willing and able to complete all planned research visits and follow the guidance of the researchers.

You may not qualify if:

  • Contact lens use: Having used contact lenses within 14 days prior to the screening visit, or refusing to commit to discontinuing contact lens use during the study period (within the next 2 months);
  • Had undergone corneal refractive surgery (e.g., LASIK/SMILE), other corneal surgeries, cataract surgery, anti-glaucoma surgery, or fundoscopic surgery within 12 months prior to enrollment screening;
  • Participation in other medical studies within 3 months prior to enrollment screening;
  • Presence of any of the following active ocular diseases at present or within 3 months prior to screening: I) Acute allergic conjunctivitis; II) Infection (by bacteria, viruses, fungi, etc.); III) Inflammation (e.g., keratitis, retinitis).
  • Meningitis, choroiditis, uveitis, scleritis, etc.;
  • Eyelid abnormalities affecting eyelid function (such as ptosis, blepharospasm, entropion, ectropion, etc.);
  • Extensive ocular surface scars or conditions that may compromise ocular surface integrity (e.g., Stevens-Johnson syndrome, history of chemical burns, persistent corneal epithelial defects, history of ocular trauma, etc.);
  • Currently or previously diagnosed with glaucoma, or undergoing treatment with anti-glaucoma medications;
  • Has used any of the following ocular medications within the past 1 month: immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, or perfluorohexyloctane;
  • Has received any of the following non-pharmacological treatments for dry eye within the past month: meibomian gland massage, deep eyelid margin cleansing, intense pulsed light therapy, or thermal pulsation therapy;
  • During pregnancy or lactation;
  • Neurological or psychiatric disorders (moderate to severe anxiety, depression, and sleep disorders);
  • Uncontrolled ocular or systemic diseases;
  • History of epilepsy;
  • The investigator determines that the subject is not suitable for participation in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmology Center, Sun Yat sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Central Study Contacts

Qi Fu

CONTACT

86+66619334fuqi@gzzoc.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 8, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Locations

CN(1)