Meibomian Gland DysfunctionNCT04920396
Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
A study testing E>Eye IRPL and Warm compress in people with Meibomian Gland Dysfunction, run by Aston University at 1 site in Canada.
Trial summary
This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress 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?
- E>Eye IRPL and Warm compress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2021to 19 Jan 2026
- 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
- Willing and able to provide informed consent and participate in the required study visit
- Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:
- OSDI score >13 and
- NITBUT <= 10sec
Who cannot join
- No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
- Patients with greater 75% meibomian gland loss
- Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
- Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
- Artificial tear usage within 2 hours prior to study testing
- Other invasive ocular diagnostic testing within 2 hours prior to study testing
- Eye makeup present on the eye lid within 10 minutes prior to study testing
Trial locations and contacts
1 site in 1 country.
About this study
This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress
Read the detailed description
E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.
The study will monitor the change in symptoms and signs of dry eye at each visit.)
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- E>Eye IRPL, Warm compress
- 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.
E>Eye IRPLDevice
Regulated intense pulsed light therapy
Warm compressDevice
Also called The Eye Doctor Mask
Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| IRPL | Experimental | Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45 Receives: Device: E>Eye IRPL |
| Warm compress | Active comparator | Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes Receives: Device: Warm compress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of dry eye disease
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
Measured: Change between baseline and day 75
Tear film stability
Change in non-invasive assessed tear film retention time from baseline to end of trial
Measured: Change between baseline and day 75
Secondary outcomes (4)
Eye redness
Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)
Measured: Change between baseline and day 75
Meibomian gland patency
Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)
Measured: Change between baseline and day 75
Tear volume
Change in tear meniscus height measured in millimeters
Measured: Change between baseline and day 75
Lipid layer thickness
Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes)
Measured: Change between baseline and day 75
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start8 Jun 2021
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Why it stopped: Failed to gain funding
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.
- 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
- Model description
- Randomized allocation between treatments
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Wolffsohn, Aston University
- Investigators
- James Wolffsohn, PhD, Principal investigator, Aston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920396
- Sponsor's protocol ID
- Eeye03182021
- Status last verified
- Jan 2026
- First submitted
- 3 Jun 2021
- Last updated
- 8 Jun 2026
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04920396
- Acronym / sponsor ID
- Eeye03182021
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failed to gain funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 9 Jun 2021 (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.
This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress
Detailed description
E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.
The study will monitor the change in symptoms and signs of dry eye at each visit.)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized allocation between treatments
| Arm | Type | Receives |
|---|---|---|
| IRPL | Experimental | Device: E>Eye IRPLThree treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45 |
| Warm compress | Active comparator | Device: Warm compressDaily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing and able to provide informed consent and participate in the required study visit
- Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to MGD, defined by the following:
Key exclusion criteria (7 listed)
- No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months
- Patients with greater 75% meibomian gland loss
- Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present
- Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours
- Artificial tear usage within 2 hours prior to study testing
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 |
|---|---|---|
| E>Eye IRPLRegulated intense pulsed light therapy | Device | IRPL |
| Warm compressAlso: The Eye Doctor MaskFabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes | Device | Warm compress |
Primary outcome
Symptoms of dry eye disease
Time frame: Change between baseline and day 75
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
Tear film stability
Time frame: Change between baseline and day 75
Change in non-invasive assessed tear film retention time from baseline to end of trial
4 secondary outcomes
Eye redness
Time frame: Change between baseline and day 75
Meibomian gland patency
Time frame: Change between baseline and day 75
Tear volume
Time frame: Change between baseline and day 75
Lipid layer thickness
Time frame: Change between baseline and day 75
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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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.
James Wolffsohn, PhD principal investigator
Aston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E>Eye IRPL and Warm compress in people with Meibomian Gland Dysfunction, run by Aston University 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 4 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: withdrawn, as of the sponsor's last update on 8 Jun 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Symptoms of dry eye disease (time frame: Change between baseline and day 75). 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 8 Jun 2026.