Meibomian Gland DysfunctionNCT01448369
Eyelid Warming Technology for Meibomian Gland Dysfunction
A study testing Blephasteam, EyeGiene and Hot compresses in people with Meibomian Gland Dysfunction, run by Singapore National Eye Centre at 1 site in Singapore.
Trial summary
Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Blephasteam, EyeGiene and Hot compresses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2011to Dec 2013
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum when MG expressed in upper or lower eyelids.
- At least one out of 8 questions on dry eye symptoms is answered with often or all the time (Appendix C, Questionnaire modified after Schein et al.,1997).
- Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Who cannot join
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Active ocular infection or pterygium.
- Anticipated necessity to wear contact lens in the duration of the study.
- Living in the same household as another participant of the study.
- Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops (eg. Restasis) not permitted by the study.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore National Eye Centre/ Singapore Eye Research Institute
Singapore, Singapore, 168751
About this study
Official title: Eyelid Warming Technology for Relief of Meibomian Gland Dysfunction in an Asian Population
Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. In MGD the meibomian glands may become blocked for various reasons. The consequential retention and stasis of the secretion increases immune response as well as scarring response. This eventually results in an abnormal tear film and dry eye symptoms.
The current standard treatments include warm moist compresses, regular lid hygiene, oral antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an extended duration is important because it relieves the occlusion of blocked meibomian glands. However, improvised methods of heating are cumbersome and inefficient requiring repeated measures, often leading to lack of compliance. Today, there is a wider range of commercially available devices that help to unblock meibomian glands and relief dry eye symptoms. These devices may improve MGD treatment dramatically, but have not been tested in the warm climate of Singapore, and are not readily available.
The current study aims to test the efficacy of treatment for devices that utilize A) warm moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks. The study will monitor patients for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented in form of questionnaires. If the newer methods of managing MGD are found to be efficacious and safe, these treatment measures can be made available to patients in Singapore.
Read the detailed description
Study Objectives and Purpose:
- A primary purpose of the study is to compare the efficacy of novel eyelid warming devices (Blephasteam and EyeGiene) for treatment of meibomian gland dysfunction by objective clinical scoring and objective assessment of ocular surface parameters in an Asian population.
- The second aim is to assess the patient acceptance of these modalities, in terms of comfort and convenience.
- A third aim of the study is to document Meibomian gland disease using non-invasive Meibography, and the possible alterations of this condition after treatment.
Study Design: Prospective, controlled, single masked, interventional study
Rationale:
Meibomian gland dysfunction and resulting evaporative dry eye is highly common in our general population. Behavioral factors and environmental stress may contribute to the severity of the disease. Eyelid warming devices have the potential to significantly improve meibomian gland health and alleviate dry eye symptoms associated with the disease. Currently eyelid warming devices suitable for treatment of meibomian gland dysfunction are not available in Singapore.
Recent technological advances, as well as the infrastructure of the Singapore Eye Research Institute (proximity to Singapore National Eye Center and pre-existing facility and infrastructure for clinical trials) have facilitated studies of products that are available elsewhere and may benefit the Singaporean population.
Methods:
Participants and target sample size Seventy-five patients from the dry eye clinic in the Singapore National Eye Center who have obstructive meibomian gland dysfunction and are keen to test alternative ways for treating the disease will be selected.
Randomisation is done by randomisation table as deemed appropriate by the statistician collaborator.
Treatment regime After informed written consent, patients will be randomly assigned to a group.
- Control group, 10-minute treatment, twice daily
- Blephasteam, 10-minute treatment, twice daily
- EyeGiene, 10-minute treatment, twice daily
All patients are permitted to continue their regular management of MGD such as use of lid scrubs or lid hygiene preparations (such as Lidcare and Blephagel). For consistency, the investigators will monitor the use of such measures in a daily diary and prohibit any other types of treatment for MGD such as Omega-3 tablets, antibiotic or steroid ointments, probing of MG.
Visit schedules Screening visit will be performed at the regular dry eye clinic. If eligible, patients will sign consent and undergo baseline examination.
Subsequent to this, the follow up visit will be after 4 weeks of treatment. A window period of
+/-3days is permitted for this visit.
Duration of study:
Four weeks.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Blephasteam, EyeGiene, Hot compresses
- Keywords
- meibomian gland dysfunction, hot compress, eyelid warming, meibum
- 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.
BlephasteamDevice
Also called Spectrum Théa, France
10 minute treatment twice daily
EyeGieneDevice
Also called Eyedetec Medical Inc., US
10 minute treatment, twice daily
Hot compressesDevice
10 minute treatment, twice daily
| Study group | Role | What they receive |
|---|---|---|
| EyeGiene | Active comparator | EyeGiene (Eyedetec Medical Inc., US) is a self-contained, convenient warm compress system for the eyes. The system is composed of a reusable eye mask and one time use warmers that are inserted into the eye mask. The warming units are activated by squeezing just prior use and deliver 40°C heat for up to 5 minutes within 30-60 seconds. Receives: Device: EyeGiene |
| Blephasteam | Active comparator | Blephasteam (Spectrum Théa, France) is an eyelid warming device that can be conveniently used at home. The goggles provide standardised heat of about 38 degrees to liquefy lipids and also humidify the chambers with mineral water to ensure optimal moisture levels. Receives: Device: Blephasteam |
| Control- Hot Compress | Placebo comparator | The participants in this group will be using warm compresses with a hot towel. Receives: Device: Hot compresses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry Eye Symptoms
A VAS will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg 2007)between baseline and week 4. The scores will be recorded separately for frequency and severity of dry eye symptoms.
Measured: Week 4
Secondary outcomes (9)
Tear film break up time
After instillation of fluorescein, the participant will be asked to open the eyes, look ahead at the observer's forehead and not blink for as long as possible. The break up time is defined as the time between the lid opening and the first appearance of any dry spot on the cornea. The participant will be requested to close his eyes for few seconds and the procedure will be repeated for the left eye. The tear film break up time will be compared between baseline and week 4.
Measured: Week 4
Number of plugs
The number of blocked/plugged meibomian glands will be counted in each eyelid and any improvement in comparison to baseline assessed.
Measured: Week 4
Yamaguchi Score
The severity of meibomian gland dysfunction will be assessed at baseline and week 4.
Measured: Week 4
Corneal Staining
The corneal staining will be assessed using fluorescein. The cornea will be divided into 5 sectors. The staining will be assessed at baseline and week 4.
Measured: Week 4
Schirmer's Test
The tear production will be assessed using Schirmer Test I. Improvements in tear production will be identified in comparison to baseline.
Measured: Week 4
Meibography
The meibomian glands will be imaged using infrared photography and their health graded at baseline and week 4.
Measured: Week 4
Tear meniscus volume
The tear meniscus (height of the tear film) will be imaged and measured using the Anterior segment optical coherence tomography (AS-OCT). Briefly, the participant will be asked to look at a target in the instrument while blinking normally. The OCT will then scan the ocular surface and images of the upper and lower tear meniscus will be captured. Any changes in tear volume will be assessed with comparison to baseline values.
Measured: Week 4
Meibomian gland lipids
The meibum from patients will be collected using a Kimura Platinum spatula and the lipid components will be analysed using mass-spectrometry. Lipid compositions will be compared between baseline and week 4 visits.
Measured: Week 4
Tear composition
The Schirmer test strips will be collected and the tears analysed for protein and lipid changes at baseline and after 4 weeks of treatment.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Eye Research Institute, National University of Singapore
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Louis Tong, PhD, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448369
- Sponsor's protocol ID
- R815/10/2011
- Other IDs
- 2011/197/A
- Status last verified
- Jun 2014
- First submitted
- 4 Oct 2011
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101. doi: 10.1016/S0161-6420(03)00262-8.
PubMed 12799232Foulks GN, Borchman D. Meibomian gland dysfunction: the past, present, and future. Eye Contact Lens. 2010 Sep;36(5):249-53. doi: 10.1097/ICL.0b013e3181ef0d37.
PubMed 20724853Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.
PubMed 27096755
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eyelid Warming Technology for Relief of Meibomian Gland Dysfunction in an Asian Population
- ClinicalTrials.gov ID
- NCT01448369
- Acronym / sponsor ID
- R815/10/2011
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- meibomian gland dysfunction, hot compress, eyelid warming, meibum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Eye Research Institute, National University of Singapore
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Oct 2011 (estimated)
- 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.
Meibomian gland dysfunction (MGD), an extremely common clinical condition (seen in more than half of some Asian populations), affects the lipid producing meibomian glands in the eyelids. One function of the glandular secretions is to reduce evaporation of the tear film. In MGD the meibomian glands may become blocked for various reasons. The consequential retention and stasis of the secretion increases immune response as well as scarring response. This eventually results in an abnormal tear film and dry eye symptoms.
The current standard treatments include warm moist compresses, regular lid hygiene, oral antibiotics, topical antibiotic ointments and Omega 3 supplementation. Heating for an extended duration is important because it relieves the occlusion of blocked meibomian glands. However, improvised methods of heating are cumbersome and inefficient requiring repeated measures, often leading to lack of compliance. Today, there is a wider range of commercially available devices that help to unblock meibomian glands and relief dry eye symptoms. These devices may improve MGD treatment dramatically, but have not been tested in the warm climate of Singapore, and are not readily available.
The current study aims to test the efficacy of treatment for devices that utilize A) warm moisture (Blephasteam) and B) warmth (EyeGiene) in patients suffering from meibomian gland dysfunction. Patients will be asked to use Blephasteam and EyeGiene for a period of 4 weeks. The study will monitor patients for changes in tear film and lipid composition, as well as changes in the anatomy of meibomian glands. Additionally, dry eye symptoms will be documented in form of questionnaires. If the newer methods of managing MGD are found to be efficacious and safe, these treatment measures can be made available to patients in Singapore.
Detailed description
Study Objectives and Purpose:
- A primary purpose of the study is to compare the efficacy of novel eyelid warming devices (Blephasteam and EyeGiene) for treatment of meibomian gland dysfunction by objective clinical scoring and objective assessment of ocular surface parameters in an Asian population.
- The second aim is to assess the patient acceptance of these modalities, in terms of comfort and convenience.
- A third aim of the study is to document Meibomian gland disease using non-invasive Meibography, and the possible alterations of this condition after treatment.
Study Design: Prospective, controlled, single masked, interventional study
Rationale:
Meibomian gland dysfunction and resulting evaporative dry eye is highly common in our general population. Behavioral factors and environmental stress may contribute to the severity of the disease. Eyelid warming devices have the potential to significantly improve meibomian gland health and alleviate dry eye symptoms associated with the disease. Currently eyelid warming devices suitable for treatment of meibomian gland dysfunction are not available in Singapore.
Recent technological advances, as well as the infrastructure of the Singapore Eye Research Institute (proximity to Singapore National Eye Center and pre-existing facility and infrastructure for clinical trials) have facilitated studies of products that are available elsewhere and may benefit the Singaporean population.
Methods:
Participants and target sample size Seventy-five patients from the dry eye clinic in the Singapore National Eye Center who have obstructive meibomian gland dysfunction and are keen to test alternative ways for treating the disease will be selected.
Randomisation is done by randomisation table as deemed appropriate by the statistician collaborator.
Treatment regime After informed written consent, patients will be randomly assigned to a group.
- Control group, 10-minute treatment, twice daily
- Blephasteam, 10-minute treatment, twice daily
- EyeGiene, 10-minute treatment, twice daily
All patients are permitted to continue their regular management of MGD such as use of lid scrubs or lid hygiene preparations (such as Lidcare and Blephagel). For consistency, the investigators will monitor the use of such measures in a daily diary and prohibit any other types of treatment for MGD such as Omega-3 tablets, antibiotic or steroid ointments, probing of MG.
Visit schedules Screening visit will be performed at the regular dry eye clinic. If eligible, patients will sign consent and undergo baseline examination.
Subsequent to this, the follow up visit will be after 4 weeks of treatment. A window period of
+/-3days is permitted for this visit.
Duration of study:
Four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EyeGiene | Active comparator | Device: EyeGieneEyeGiene (Eyedetec Medical Inc., US) is a self-contained, convenient warm compress system for the eyes. The system is composed of a reusable eye mask and one time use warmers that are inserted into the eye mask. The warming units are activated by squeezing just prior use and deliver 40°C heat for up to 5 minutes within 30-60 seconds. |
| Blephasteam | Active comparator | Device: BlephasteamBlephasteam (Spectrum Théa, France) is an eyelid warming device that can be conveniently used at home. The goggles provide standardised heat of about 38 degrees to liquefy lipids and also humidify the chambers with mineral water to ensure optimal moisture levels. |
| Control- Hot Compress | Placebo comparator | Device: Hot compressesThe participants in this group will be using warm compresses with a hot towel. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum when MG expressed in upper or lower eyelids.
- At least one out of 8 questions on dry eye symptoms is answered with often or all the time (Appendix C, Questionnaire modified after Schein et al.,1997).
- Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.
Key exclusion criteria (7 listed)
- Known history of thyroid disorders (diagnosed by physician).
- No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- Active ocular infection or pterygium.
- Anticipated necessity to wear contact lens in the duration of the study.
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 |
|---|---|---|
| BlephasteamAlso: Spectrum Théa, France10 minute treatment twice daily | Device | Blephasteam |
| EyeGieneAlso: Eyedetec Medical Inc., US10 minute treatment, twice daily | Device | EyeGiene |
| Hot compresses10 minute treatment, twice daily | Device | Control- Hot Compress |
Primary outcome
Dry Eye Symptoms
Time frame: Week 4
A VAS will be applied to evaluate dry eye symptoms as described by Schaumberg et al. (Schaumberg 2007)between baseline and week 4. The scores will be recorded separately for frequency and severity of dry eye symptoms.
9 secondary outcomes
Tear film break up time
Time frame: Week 4
Number of plugs
Time frame: Week 4
Yamaguchi Score
Time frame: Week 4
Corneal Staining
Time frame: Week 4
Schirmer's Test
Time frame: Week 4
Meibography
Time frame: Week 4
Tear meniscus volume
Time frame: Week 4
Meibomian gland lipids
Time frame: Week 4
Tear composition
Time frame: Week 4
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 10 Jun 2014.
- Background: PubMed 12799232Lin PY, Tsai SY, Cheng CY, Liu JH, Chou P, Hsu WM. Prevalence of dry eye among an elderly Chinese population in Taiwan: the Shihpai Eye Study. Ophthalmology. 2003 Jun;110(6):1096-101. doi: 10.1016/S0161-6420(03)00262-8.
- Background: PubMed 20724853Foulks GN, Borchman D. Meibomian gland dysfunction: the past, present, and future. Eye Contact Lens. 2010 Sep;36(5):249-53. doi: 10.1097/ICL.0b013e3181ef0d37.
- Derived from this study: PubMed 27096755Yeo S, Tan JH, Acharya UR, Sudarshan VK, Tong L. Longitudinal Changes in Tear Evaporation Rates After Eyelid Warming Therapies in Meibomian Gland Dysfunction. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(4):1974-81. doi: 10.1167/iovs.16-19088.
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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.
Louis Tong, PhD principal investigator
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blephasteam, EyeGiene and Hot compresses in people with Meibomian Gland Dysfunction, run by Singapore National Eye Centre at 1 site in Singapore.
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 7 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 10 Jun 2014. 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 Singapore. 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?
Dry Eye Symptoms (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01448369, which also lists 3 linked publications.
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 10 Jun 2014.