Meibomian Gland Dysfunction (MGD)HummingbirdNCT02284997
The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction
A study testing MGDRx® EyeBag in people with Meibomian Gland Dysfunction (MGD), run by University of Waterloo at 1 site in Canada.
Trial summary
Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glands may become obstructed due to change in meibum quality. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction (MGD)
- What is being tested?
- MGDRx® EyeBag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Apr 2015
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A person is eligible for inclusion in the study if he/she:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- OSDI score ≥ 23;
- Meibomian gland score of ≤ 9 (out of 15).
Show all 9Show fewer
- Is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen
- Agree to using MetricWire for online data entry
- Is not a contact lens wearer (Infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)).
Who cannot join
- A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical or research study;
- Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
Show all 10Show fewer
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment, as determined verbally;
- Is aphakic;
- Has undergone refractive error surgery; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. An exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glands may become obstructed due to change in meibum quality. When meibum thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment for MGD is a procedure called "warm compresses". It is a combination of applying heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland openings, and allow oils to flow normally onto the tear film once again. One way to apply heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes are gently massaged afterwards.
The purpose of this study is to determine how effective the EyeBag is at improving MGD and dry eye symptoms.
- Conditions
- Meibomian Gland Dysfunction (MGD)
- Being tested
- MGDRx® EyeBag
- 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.
MGDRx® EyeBagDevice
Class 1 Medical Device, registered with the Medicines and Healthcare products Regulatory Agency. UK Patent: GB2421687B. The EyeBag is made of silk and 100% brushed black cotton and filled with flax / linseed. When heated, this device is intended to warm the eyelids. This melts the meibum and clears the meibum obstruction of the MGs.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will be instructed to use a warming MGDRx® EyeBag for minimum of 10 minutes, twice a day Receives: Device: MGDRx® EyeBag |
| Control | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian gland score (MGS)
Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Measured: Baseline
Meibomian gland score (MGS)
Eight weeks after treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Measured: 8 weeks after baseline/treatment visit
Meibomian gland yielding liquid secretions (MGYLS)
Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
Measured: Baseline
Meibomian gland yielding liquid secretions (MGYLS)
MGYLS is the number of glands with MGS grade 2 or higher.
Measured: 8 weeks after baseline/treatment visit
Ocular Surface Disease Index Score (OSDI)
Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Measured: Baseline
Ocular Surface Disease Index Score (OSDI)
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Measured: 8 weeks after baseline/treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland Dysfunction (MGD)Studies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndon Jones, PhD, Principal investigator, CCLR, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284997
- Sponsor's protocol ID
- 20246
- Acronym
- Hummingbird
- Status last verified
- May 2015
- First submitted
- 3 Nov 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT02284997
- Acronym / sponsor ID
- Hummingbird / 20246
- Conditions
- Meibomian Gland Dysfunction (MGD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Nov 2014 (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.
Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glands may become obstructed due to change in meibum quality. When meibum thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment for MGD is a procedure called "warm compresses". It is a combination of applying heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland openings, and allow oils to flow normally onto the tear film once again. One way to apply heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes are gently massaged afterwards.
The purpose of this study is to determine how effective the EyeBag is at improving MGD and dry eye symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: MGDRx® EyeBagParticipants will be instructed to use a warming MGDRx® EyeBag for minimum of 10 minutes, twice a day |
| Control | No intervention | –No treatment |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- OSDI score ≥ 23;
- Meibomian gland score of ≤ 9 (out of 15).
Key exclusion criteria (10 listed)
- Is participating in any concurrent clinical or research study;
- Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
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 |
|---|---|---|
| MGDRx® EyeBagClass 1 Medical Device, registered with the Medicines and Healthcare products Regulatory Agency. UK Patent: GB2421687B. The EyeBag is made of silk and 100% brushed black cotton and filled with flax / linseed. When heated, this device is intended to warm the eyelids. This melts the meibum and clears the meibum obstruction of the MGs. | Device | Treatment |
Primary outcome
Meibomian gland score (MGS)
Time frame: Baseline
Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Meibomian gland score (MGS)
Time frame: 8 weeks after baseline/treatment visit
Eight weeks after treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Meibomian gland yielding liquid secretions (MGYLS)
Time frame: Baseline
Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
Meibomian gland yielding liquid secretions (MGYLS)
Time frame: 8 weeks after baseline/treatment visit
MGYLS is the number of glands with MGS grade 2 or higher.
Ocular Surface Disease Index Score (OSDI)
Time frame: Baseline
Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Ocular Surface Disease Index Score (OSDI)
Time frame: 8 weeks after baseline/treatment visit
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
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 29 May 2015.
Related trials for Meibomian Gland Dysfunction (MGD)
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
The Effect of Eyelid Support Plate Assisted Eyelid Massage on Meibomian Gland Dysfunction: a Randomized Controlled Trial
Dry Eye Disease (DED), MGD-Meibomian Gland Dysfunction
RecruitingPhase 4
Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction
Meibomian Gland Dysfunction (MGD)
Recruiting
Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD
Dry Eye Syndromes, Meibomian Gland Dysfunction
Not yet recruitingObservational study
A Study to Evaluate the Safety and Effectiveness of Perfluorohexyloctane Eye Drops on Treatment of Dry Eye Disease (DED) Related to Meibomian Gland Dysfunction (MGD)
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.
Lyndon Jones, PhD principal investigator
CCLR, University of Waterloo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGDRx® EyeBag in people with Meibomian Gland Dysfunction (MGD), run by University of Waterloo at 1 site in Canada.
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 9 inclusion and 10 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 29 May 2015. 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 Canada. 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 score (MGS) (time frame: Baseline). The study lists 6 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 29 May 2015.