MGD-Meibomian Gland DysfunctionNCT03104894
The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
A study testing Meibomian Glands Massage and Meibomian Massage device in people with MGD-Meibomian Gland Dysfunction, run by Barzilai Medical Center at 1 site in Israel.
Trial summary
The study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone. The meibomian glands secrete meibum which is the oily component of the tear film layer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MGD-Meibomian Gland Dysfunction
- What is being tested?
- Meibomian Glands Massage and Meibomian Massage device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.
Who cannot join
- pregnant women, subjects who received prior Meibomian gland massage.
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone.
The meibomian glands secrete meibum which is the oily component of the tear film layer. The meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .
Read more
Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are rosacea and dry eye syndrome .
Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and blur.
Spectrometry analysis shows change it the fatty acids conformation such as increase in levels of branched-chain fatty acids and decrease in saturated fatty acids .
Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion granular-toothpaste like.
Although MGD is not often accompanied with inflammatory signs it is a common cause for evaporative dry eye.
Read the detailed description
In order to investigate the relation between meibomian gland massage outcomes and signs and symptoms of dry eye, randomized prospective study will be conducted. Patients, who arrive to Barzilai Medical Center out patients' clinic, are diagnosed with MGD 2-3 and signed informed consent form shall be included in the trial, then randomized to study group or control group.
The study group will receive meibomian glands massage and artificial drops PRN, whereas the control group will receive sham massage and artificial drops. Each visit at the clinic will include dry examinations and questionnaire.
Follow up examination are due after one week, monthly visits up to 4 months, then after half year, 8 months and one year.
Statistical methods: in order to evaluate to treatment effect T-Test analysis will be calculated, significant result is when P<0.05.
Data will be recorded into to electronic sheets. Subjects' confidentiality will be assured by masking any identifying details and a random number will be assigned prior results analysis stage
- Conditions
- MGD-Meibomian Gland Dysfunction
- Being tested
- Meibomian Glands Massage, Sham Meibomian Glands Massage, Meibomian Massage device
- 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 Glands MassageProcedure or surgery
Meibomian gland expression
Sham Meibomian Glands MassageProcedure or surgery
Touching the eyelids gently
Meibomian Massage deviceDevice
Meibomian glands expression with applicator
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The study group will receive meibomian glands massage and artificial drops PRN Receives: Procedure: Meibomian Glands Massage; Device: Meibomian Massage device |
| Control Group | Sham comparator | The control group will receive sham meibomian glands massage and artificial drops PRN. Receives: Procedure: Sham Meibomian Glands Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Tear Break up Time TBUT.
Tear break up time will be measured in seconds. The score is expected to be higher.
Measured: 1 month
Improvement in Ocular Surface Disease Index questionnaire score (OSDI)
OSDI score will be calculated according a formula: (sum of scores) X 25 divided by the number of questions answered. The score is expected to be lower.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startAug 2015
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MGD-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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barzilai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104894
- Sponsor's protocol ID
- 0137-13-BRZ
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- 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 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Meibomian Glands Massage on Signs and Symptoms of Dry Eye
- ClinicalTrials.gov ID
- NCT03104894
- Acronym / sponsor ID
- 0137-13-BRZ
- Conditions
- MGD-Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Barzilai Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Apr 2017 (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 study aims to investigate whether combined treatment of MGD massage and artificial tears will improve signs and symptoms of dry eye compared to artificial tears alone.
The meibomian glands secrete meibum which is the oily component of the tear film layer. The meibum plays a pivotal role in preventing tear evaporation and smoothening the tears film .
Meibomian gland dysfunction is a common condition that affects 39%-50% of the population. It is part of inflammatory disease of the eyelids called blepharitis. Associated syndromes are rosacea and dry eye syndrome .
Sign and symptoms are: irritation, hyperemia, burning sensation, photophobia, epiphora and blur.
Spectrometry analysis shows change it the fatty acids conformation such as increase in levels of branched-chain fatty acids and decrease in saturated fatty acids .
Subsequently the clotted meibum results in glands blockage that can be graded in 0-4 grade scale: grade 2- meibum secretion thick and oily, grade 3- meibum secretion granular-toothpaste like.
Although MGD is not often accompanied with inflammatory signs it is a common cause for evaporative dry eye.
Detailed description
In order to investigate the relation between meibomian gland massage outcomes and signs and symptoms of dry eye, randomized prospective study will be conducted. Patients, who arrive to Barzilai Medical Center out patients' clinic, are diagnosed with MGD 2-3 and signed informed consent form shall be included in the trial, then randomized to study group or control group.
The study group will receive meibomian glands massage and artificial drops PRN, whereas the control group will receive sham massage and artificial drops. Each visit at the clinic will include dry examinations and questionnaire.
Follow up examination are due after one week, monthly visits up to 4 months, then after half year, 8 months and one year.
Statistical methods: in order to evaluate to treatment effect T-Test analysis will be calculated, significant result is when P<0.05.
Data will be recorded into to electronic sheets. Subjects' confidentiality will be assured by masking any identifying details and a random number will be assigned prior results analysis stage
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: Meibomian Glands Massage, Device: Meibomian Massage deviceThe study group will receive meibomian glands massage and artificial drops PRN |
| Control Group | Sham comparator | Procedure: Sham Meibomian Glands MassageThe control group will receive sham meibomian glands massage and artificial drops PRN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Individuals (age≥18Y) with MGD levels 2-3 that are capable to make an informed decision about their participation in the trial.
Key exclusion criteria (1 listed)
- pregnant women, subjects who received prior Meibomian gland massage.
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 Glands MassageMeibomian gland expression | Procedure or surgery | Study Group |
| Sham Meibomian Glands MassageTouching the eyelids gently | Procedure or surgery | Control Group |
| Meibomian Massage deviceMeibomian glands expression with applicator | Device | Study Group |
Primary outcome
Improvement in Tear Break up Time TBUT.
Time frame: 1 month
Tear break up time will be measured in seconds. The score is expected to be higher.
Improvement in Ocular Surface Disease Index questionnaire score (OSDI)
Time frame: 1 month
OSDI score will be calculated according a formula: (sum of scores) X 25 divided by the number of questions answered. The score is expected to be lower.
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 23 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for MGD-Meibomian Gland Dysfunction
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Not yet recruiting
TearCare in Young Adults
Meibomian Gland Dysfunction (Disorder)
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Enrolling by invitation
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Dry Eye, Evaporative Dry Eye Disease
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 Glands Massage and Meibomian Massage device in people with MGD-Meibomian Gland Dysfunction, run by Barzilai Medical Center at 1 site in Israel.
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 1 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 23 Jan 2018. 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 Israel. 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.
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?
Improvement in Tear Break up Time TBUT. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 23 Jan 2018.