Meibomian Gland DysfunctionNCT06163105
The Effect of Gland Expression on the Regeneration of Meibomian Gland
A study testing Meibomian gland expression (MGX) in people with Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare the percentage of meibomian gland (MG) dropout in patients who are treated with additional meibomian gland expression (MGX) and in patients who are not. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Meibomian gland expression (MGX)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 3 Oct 2024to 6 Mar 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of obstructive MGD
- Visible Meibomian gland dropout of upper and lower eyelid from grade 1 to grade 2 (Arita's meiboscale)
- If both eyes meet above criteria, only right eye is chosen
Who cannot join
- Diagnosis with secondary MGD
- Having any eyedrop other than eye lubricant within the last 3 months
- Any kind of eyelid treatment related to MGD within the last 6 months
- History of ocular trauma, ocular surface surgery or eyelid surgery
- History of intraocular surgery less than 6 months
- Eyelid botulinum toxin injection within the last 6 months
Show all 11Show fewer
- Ocular diseases other than dry eye
- Pregnant or breast-feeding
- Wearing contact lens
- Using any hormones therapy, anti-inflammatory drugs, tetracycline and macrolides
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare the percentage of meibomian gland (MG) dropout in patients who are treated with additional meibomian gland expression (MGX) and in patients who are not. The main question[s] it aims to answer are:
- Does additional MGX reverse MG dropout and support regeneration of MG?
- Does additional MGX have better effect on tear film stability, MG function, lid morphology, tear cytokines than lid hygiene alone?
Read more
Methods:
Participants will be randomly assigned into MGX group as a treatment group and control group to assess study outcomes. The basic treatment of the 2 groups included lid hygiene once daily and artificial tear. The treatment duration lasts for 12 weeks. Patients will be examined at baseline, at 4-week, 8-week, 12-week visit for MG dropout percentage, MG morphology, lid margin abnormalities, Meibum assessment, tear film, tear cytokines and pain score to see if additional MGX can regenerate MG better than lid hygiene alone.
Read the detailed description
- Study design: an assessor-blinded, randomized, controlled trial
- Target population: MGD patients having mild to moderate MG dropout from Out-clinic at King Chulalongkorn Memorial Hospital (KCMH).
- Randomization and blinding Permuted block randomization will be used. After recruiting in this study, participants who meet the eligibility criteria will be divided into 2 groups by research assistant. There is an independent ophthalmologist (A.L) who is blinded to treatment allocation.
5)Data collection Demographic characteristics, numeric rating scale-11 (NRS-11) and ocular surface disease index (OSDI) will be collected by interviewing. Other parameters will be collected by slit lamp examination, specific machines or further investigations. All the data will be filled in the medical record. The participants will be identified on medical record by a unique research number, not by name or identification (ID) number (apart from on the consent form and enrollment log). Patient's ID, name, surname, and phone number will be stored in different file by the research assistant. The data will be locked up and destroyed 5 years after the study ends.
When the patients are recruited in the study, the patients will be provided information sheet and explained about the study. If the patients agree to participate in the study, they will be asked to sign the consent form. Then, they will be appointed to return to the Refractive Surgery Center in the next day for examination and tear collection between 1 pm to 3 pm because some cytokines are independent diurnal rhythms.
All outcome data will be collected by one single masked investigator (A.L). The data will be collected at 4 time points (day 0, week 4, week 8 and week 12). At baseline and 12-week post treatment, participants are required to be at the hospital on time within the period of 1 pm to 3 pm for tear collection. In each visit, the examination must be done in correct order in order not to avoid the results of outcomes. These steps include:
- Tear collection
- Evaluating the ocular symptoms
- Measuring lipid layer thickness
- Slit-lamp examination (tear break up time, lid margin abnormality, meibum expressibility and meibum quality)
- Non-contact infrared Meibography
- Evaluating adverse events
- Sample size: There is no previous study showing the difference in Meibomian gland dropout area between these groups. Our expert's opinion about minimal clinical difference is 10%. The standard deviation of meibomian gland dropout area in obstruction MGD patients is 16.7%. We use the formula for a trial with an equal allocation ratio and repeated measurements. This will be inflated for a 10% drop out, giving a total sample size of 32 per group (total sample size of 64).
- Statistical analysis:
Stata (version 17) software are utilized. All statistical analyses were undertaken by a researcher who are blinded to group allocation. The data were analyzed using an intention-to-treat (ITT) framework, which included all participants randomized in the study, regardless of the treatment type or exposure received. Per protocol (PP) is added as a supportive analysis. PP analysis will exclude the participants who do the lid hygiene less than 20 days per month or using any other treatment than advice. A significance level of 5% was used in all statistical tests.
Demographic data will be interpreted by descriptive analysis. The primary outcome is the change in meibomian gland percentages of each eyelid from baseline over all follow-up visits analyzing by linear mixed models with random intercept for patient, adjusting for baseline Meibomian gland percentage in the study participants and modelling time as a discrete variable. Marginal models will be used to predict the discrete changes at each study month. OSDI, tear break up time and lipid layer thickness are analyzed by linear mixed models (LMM). Lid abnormalities, meibum score and MG morphology will be analyzed by generalized linear mixed model (GLMM). Cytokine levels will be analyzed by unpaired t test.
- Missing data management: If a patient chooses to withdraw from the study, the reason for withdrawal will be documented. These reasons will be valuable for analyzing the results later on. Multiple imputation method will be used to handle with missing data.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Meibomian gland expression (MGX)
- Keywords
- Meibomian gland expression, squeezing, Regeneration, Morphology
- 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.
Meibomian gland expression (MGX)Procedure or surgery
Also called Meibomian gland squeezing
The MGX procedure has a standardized protocol in lid spa at Chula's Refractive Surgery Center every 2 weeks (totally 6 sessions). During the study, all MGX procedures will be conducted by the same nurse following these steps:
- Topical anesthesia by Tetracaine 0.5%
- Clean the eyelids by gauzes with commercial available foam
- Warm the eyelids by Blephasteam machine for 10 minutes
- Instill Tetracaine 0.5% again
- Use Mastrota paddle and Q-tip to squeeze the gland
- Clean the lid margin by commercial available foam
- Use Moxifloxacin 0.5% eyedrop
| Study group | Role | What they receive |
|---|---|---|
| Meibomian gland expression (MGX) | Experimental | * In-office MGX every 2 weeks
* Lid hygiene at home once daily for 12 weeks
* Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks Receives: Procedure: Meibomian gland expression (MGX) |
| Control group | No intervention | * Lid hygiene at home once daily for 12 weeks * Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian gland dropout percentage
The dropout percentage of upper and lower eyelid is calculated by (Area of Meibomian gland dropout) / (Area of tarsal plate)*100%. Non-contact infrared Meibography is carried out using Oculus Keratograph 5M with upper and lower eyelids everted consecutively. To calculate the dropout area percentage of each eyelid, the investigator analyzes the images by utilizing the ImageJ software.
Measured: Baseline, week 4, week 8, week 12
Secondary outcomes (7)
Meibomian gland morphology
Meibomian gland morphology includes:
- Distorted glands: glands not parallel to normal glands with torsion ≤45°
- Tortuous glands: glands not parallel to normal glands with torsion >45°
- Hooked glands: glands curling back at the distal end
- Overlapping glands These variables are binary variables (Yes/No) They are analyzed by meibography images taken by Keratograph 5M
Measured: Baseline, week 4, week 8, week 12
Lipid layer thickness
Lipid layer thickness measurement by Lipiview interferometer. For each eye, a 20-second video will be recorded to quantify the thickness of tear film's lipid layer in interferometric color unit (ICU) which corresponds to 1 nanometer. Images are captured while the participant focuses on the internal target. They are allowed to blink naturally during this process. Patients should not use any artificial tear for at least 4 hours and should not use ointments for at least 24 hours prior to LipiView assessment.
Measured: Baseline, week 4, week 8, week 12
Lid margin abnormality
Lid margin abnormality score in upper and lower eyelid will be calculated by summing the score of 4 aspects:
- Telangiectasia (0: No or slight redness in lid margin conjunctiva and no telangiectasia, 1: Redness in lid margin conjunctiva and no telangiectasia crossing meibomian gland orifices, 2: conjunctival redness and telangiectasia < 1/2 full length of the lid, 3: conjunctival redness and telangiectasia ≥ 1/2 full length of the lid)
- Plugging (0: No plugging, 1: < 3 plugging, 2: ≥3 plugging with a distribution of <1/2 full length of the lid, 3: ≥3 plugging with a distribution of ≥ 1/2 full length of the lid)
- Thickening (0: No thickening, 1: Lid margin thickening with or without localized rounding, 2: diffuse rounding)
- Irregularity (0: No irregularity, 1: <3 lid margin irregularities with shallow notching, 2: ≥3 lid margin irregularities or deep notching)
Measured: Baseline, week 4, week 8, week 12
Meibum quality
The meibum quality score was conducted by Evaluator (TearScience). Meibum quality score is obtained by evaluate each of eight glands of the central third of the lower eyelid on a scale of 0 to 3 for each gland (0: clear, 1: cloudy, 2: Cloudy with debris (granular), 3: Thick, like toothpaste). Total score ranges from 0 to 24.
Measured: Baseline, week 4, week 8, week 12
Meibum expressibility
The meibum expressibility score was conducted by Evaluator (TearScience). Meibum expressibility is evaluated on a scale ranging from 0 to 3 for five glands of the lower eyelid. The assessment is based on the number of glands that can be expressed.
0: All glands, 1: 3-4 glands, 2: 1-2 glands, 3: no gland
Measured: Baseline, week 4, week 8, week 12
Pain level
MGX group is assessed pain level by interview the patients within 15 minutes after the procedure by a numeric rating scale-11 (NRS-11). Pain levels ranges from 0 to 10 as follows: 0, no pain; 10, worst possible pain; 1 to 3, mild pain; 4 to 6, moderate pain; and 7 to 10, severe pain
Measured: Baseline, week 2, week 4, week 6, week 8, week 10
Adverse events
Adverse events will be questioned and recorded after the MGX and in every follow-up visit (week 4, week 8 and week 12) in both 2 groups. The examination using slit-lamp biomicroscopy to examine the eyelashes, eyelids, conjunctiva, cornea, anterior chamber, and lens is performed to detect any adverse events such as conjunctival congestion and eyelid puffiness, subconjunctival/lid hemorrhages, chalazion, acute conjunctivitis and keratitis.
Measured: week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start3 Oct 2024
- Primary completion6 Mar 2025
- Study completion6 Mar 2025
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 Chulalongkorn UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Responsible party
- Principal investigator, Ngoc Van Anh Le, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163105
- Sponsor's protocol ID
- 0868/66
- Status last verified
- Mar 2025
- First submitted
- 30 Nov 2023
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gland Expression on the Regeneration of Meibomian Gland
- ClinicalTrials.gov ID
- NCT06163105
- Acronym / sponsor ID
- 0868/66
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian gland expression, squeezing, Regeneration, Morphology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 6 Mar 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 8 Dec 2023 (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.
The goal of this clinical trial is to compare the percentage of meibomian gland (MG) dropout in patients who are treated with additional meibomian gland expression (MGX) and in patients who are not. The main question[s] it aims to answer are:
- Does additional MGX reverse MG dropout and support regeneration of MG?
- Does additional MGX have better effect on tear film stability, MG function, lid morphology, tear cytokines than lid hygiene alone?
Methods:
Participants will be randomly assigned into MGX group as a treatment group and control group to assess study outcomes. The basic treatment of the 2 groups included lid hygiene once daily and artificial tear. The treatment duration lasts for 12 weeks. Patients will be examined at baseline, at 4-week, 8-week, 12-week visit for MG dropout percentage, MG morphology, lid margin abnormalities, Meibum assessment, tear film, tear cytokines and pain score to see if additional MGX can regenerate MG better than lid hygiene alone.
Detailed description
- Study design: an assessor-blinded, randomized, controlled trial
- Target population: MGD patients having mild to moderate MG dropout from Out-clinic at King Chulalongkorn Memorial Hospital (KCMH).
- Randomization and blinding Permuted block randomization will be used. After recruiting in this study, participants who meet the eligibility criteria will be divided into 2 groups by research assistant. There is an independent ophthalmologist (A.L) who is blinded to treatment allocation.
5)Data collection Demographic characteristics, numeric rating scale-11 (NRS-11) and ocular surface disease index (OSDI) will be collected by interviewing. Other parameters will be collected by slit lamp examination, specific machines or further investigations. All the data will be filled in the medical record. The participants will be identified on medical record by a unique research number, not by name or identification (ID) number (apart from on the consent form and enrollment log). Patient's ID, name, surname, and phone number will be stored in different file by the research assistant. The data will be locked up and destroyed 5 years after the study ends.
When the patients are recruited in the study, the patients will be provided information sheet and explained about the study. If the patients agree to participate in the study, they will be asked to sign the consent form. Then, they will be appointed to return to the Refractive Surgery Center in the next day for examination and tear collection between 1 pm to 3 pm because some cytokines are independent diurnal rhythms.
All outcome data will be collected by one single masked investigator (A.L). The data will be collected at 4 time points (day 0, week 4, week 8 and week 12). At baseline and 12-week post treatment, participants are required to be at the hospital on time within the period of 1 pm to 3 pm for tear collection. In each visit, the examination must be done in correct order in order not to avoid the results of outcomes. These steps include:
- Tear collection
- Evaluating the ocular symptoms
- Measuring lipid layer thickness
- Slit-lamp examination (tear break up time, lid margin abnormality, meibum expressibility and meibum quality)
- Non-contact infrared Meibography
- Evaluating adverse events
- Sample size: There is no previous study showing the difference in Meibomian gland dropout area between these groups. Our expert's opinion about minimal clinical difference is 10%. The standard deviation of meibomian gland dropout area in obstruction MGD patients is 16.7%. We use the formula for a trial with an equal allocation ratio and repeated measurements. This will be inflated for a 10% drop out, giving a total sample size of 32 per group (total sample size of 64).
- Statistical analysis:
Stata (version 17) software are utilized. All statistical analyses were undertaken by a researcher who are blinded to group allocation. The data were analyzed using an intention-to-treat (ITT) framework, which included all participants randomized in the study, regardless of the treatment type or exposure received. Per protocol (PP) is added as a supportive analysis. PP analysis will exclude the participants who do the lid hygiene less than 20 days per month or using any other treatment than advice. A significance level of 5% was used in all statistical tests.
Demographic data will be interpreted by descriptive analysis. The primary outcome is the change in meibomian gland percentages of each eyelid from baseline over all follow-up visits analyzing by linear mixed models with random intercept for patient, adjusting for baseline Meibomian gland percentage in the study participants and modelling time as a discrete variable. Marginal models will be used to predict the discrete changes at each study month. OSDI, tear break up time and lipid layer thickness are analyzed by linear mixed models (LMM). Lid abnormalities, meibum score and MG morphology will be analyzed by generalized linear mixed model (GLMM). Cytokine levels will be analyzed by unpaired t test.
- Missing data management: If a patient chooses to withdraw from the study, the reason for withdrawal will be documented. These reasons will be valuable for analyzing the results later on. Multiple imputation method will be used to handle with missing data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meibomian gland expression (MGX) | Experimental | Procedure: Meibomian gland expression (MGX)* In-office MGX every 2 weeks * Lid hygiene at home once daily for 12 weeks * Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks |
| Control group | No intervention | –* Lid hygiene at home once daily for 12 weeks * Preservative-free artificial tears (0.18% sodium hyaluronate) 4 times daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of obstructive MGD
- Visible Meibomian gland dropout of upper and lower eyelid from grade 1 to grade 2 (Arita's meiboscale)
- If both eyes meet above criteria, only right eye is chosen
Key exclusion criteria (11 listed)
- Diagnosis with secondary MGD
- Having any eyedrop other than eye lubricant within the last 3 months
- Any kind of eyelid treatment related to MGD within the last 6 months
- History of ocular trauma, ocular surface surgery or eyelid surgery
- History of intraocular surgery less than 6 months
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 |
|---|---|---|
| Meibomian gland expression (MGX)Also: Meibomian gland squeezingThe MGX procedure has a standardized protocol in lid spa at Chula's Refractive Surgery Center every 2 weeks (totally 6 sessions). During the study, all MGX procedures will be conducted by the same nurse following these steps: 1. Topical anesthesia by Tetracaine 0.5% 2. Clean the eyelids by gauzes with commercial available foam 3. Warm the eyelids by Blephasteam machine for 10 minutes 4. Instill Tetracaine 0.5% again 5. Use Mastrota paddle and Q-tip to squeeze the gland 6. Clean the lid margin by commercial available foam 7. Use Moxifloxacin 0.5% eyedrop | Procedure or surgery | Meibomian gland expression (MGX) |
Primary outcome
Meibomian gland dropout percentage
Time frame: Baseline, week 4, week 8, week 12
The dropout percentage of upper and lower eyelid is calculated by (Area of Meibomian gland dropout) / (Area of tarsal plate)*100%. Non-contact infrared Meibography is carried out using Oculus Keratograph 5M with upper and lower eyelids everted consecutively. To calculate the dropout area percentage of each eyelid, the investigator analyzes the images by utilizing the ImageJ software.
7 secondary outcomes
Meibomian gland morphology
Time frame: Baseline, week 4, week 8, week 12
Lipid layer thickness
Time frame: Baseline, week 4, week 8, week 12
Lid margin abnormality
Time frame: Baseline, week 4, week 8, week 12
Meibum quality
Time frame: Baseline, week 4, week 8, week 12
Meibum expressibility
Time frame: Baseline, week 4, week 8, week 12
Pain level
Time frame: Baseline, week 2, week 4, week 6, week 8, week 10
Adverse events
Time frame: week 4, week 8 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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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 study testing Meibomian gland expression (MGX) in people with Meibomian Gland Dysfunction, run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 17 Mar 2025. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Meibomian gland dropout percentage (time frame: Baseline, week 4, week 8, week 12). 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 17 Mar 2025.