Dry EyeNCT07618169
Comparative Effects of USB-Powered Warm Compress and Self-Heating Eye Mask in the Management of Meibomian Gland Dysfunction
A study testing USB-Powered Warm Compress and Self-Heating Eye Mask in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Why was this study done? People with Meibomian Gland Dysfunction (MGD) often have dry, irritated eyes because the tiny oil glands in their eyelids do not work properly. Applying gentle heat to the eyelids is a common way to improve the flow of oil and relieve symptoms. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye, MGD-Meibomian Gland Dysfunction
- What is being tested?
- USB-Powered Warm Compress and Self-Heating Eye Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Jan 2025to 30 May 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-40 years diagnosed with Meibomian Gland Dysfunction (MGD).
- Baseline NITBUT < 10 seconds.
- Willing to discontinue other lid therapies during the study period.
Who cannot join
- Active ocular infection or inflammation.
- Recent ocular surgery (<3 months).
- Use of contact lenses during the study period.
- Systemic diseases affecting tear film (e.g., Sjögren's syndrome).
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University
Riyadh, Central Region, RIAYDH 113
About this study
Official title: USB-Powered vs. Self-Heating Warm Compresses for Meibomian Gland Dysfunction: A Prospective Randomized Crossover Trial
Why was this study done?
People with Meibomian Gland Dysfunction (MGD) often have dry, irritated eyes because the tiny oil glands in their eyelids do not work properly. Applying gentle heat to the eyelids is a common way to improve the flow of oil and relieve symptoms.
Read more
This study wanted to find out whether a USB-powered warm compress or a self-heating disposable eye mask works better and feels more comfortable for patients with MGD.
Who took part?
Adults diagnosed with Meibomian Gland Dysfunction were invited to participate. Each person tried both treatments, one after the other, with a short break between them (this is called a crossover design).
What did participants do?
In one treatment phase, participants used a USB-powered warm compress for about 10 minutes per day over two weeks.
In the other phase, they used a self-heating disposable eye mask for the same amount of time.
The order of treatments was randomized to avoid bias.
Before and after each treatment, eye tests and comfort questionnaires were completed.
What did the study measure?
The main goal was to see if the treatments improved:
Tear film stability (how long the tears stay on the eye surface)
Meibomian gland function (how well the glands release oil)
Eye comfort and dryness symptoms
What were the results?
Both the USB-powered warm compress and the self-heating eye mask helped improve tear stability and comfort.
However, the USB-powered device provided slightly better results in improving gland function and patient satisfaction.
No serious side effects or discomfort were reported.
What do these results mean?
Regular eyelid warming is an effective way to manage MGD and dry eye symptoms. Both devices are safe and easy to use, but a USB-powered warm compress may offer stronger and more consistent heat for better results.
Patients and eye-care professionals can choose the device that best fits daily routines, comfort, and lifestyle.
Who conducted the study?
The study was carried out by optometrists and vision scientists specializing in ocular surface disease and dry eye therapy.
It followed ethical approval and was reviewed by an institutional research board before beginning.
Why is this study important?
MGD is one of the most common causes of dry eye disease worldwide. Understanding which home-based treatment works best helps patients, families, and clinicians make informed choices about safe and effective care options.
Read the detailed description
Meibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye, characterized by obstruction and altered secretion of the meibomian glands that results in tear film instability and ocular discomfort. Thermal therapy is considered a cornerstone in the management of MGD, as controlled eyelid warming can enhance lipid flow, reduce stagnation, and restore tear film quality. However, the effectiveness and convenience of commercially available warming devices may vary depending on their design and heat delivery mechanisms.
This randomized, prospective, crossover clinical trial was designed to compare the efficacy and user experience of two commonly used warming modalities: a USB-powered eyelid warming device and a disposable self-heating eye mask. Each participant received both interventions in separate treatment phases, with a washout period in between, to minimize inter-subject variability. The order of intervention was randomized, ensuring balanced exposure across participants.
The study primarily aimed to assess changes in tear film stability and meibomian gland function following each treatment. Additional measures included ocular surface comfort, tear meniscus height, and patient preference. Standardized clinical assessments were conducted before and after each intervention phase, and validated questionnaires were used to capture subjective symptoms and usability feedback. Safety and tolerability were monitored throughout all sessions.
This investigation sought to generate comparative data on the short-term outcomes of two practical home-based treatment methods for MGD. The crossover design provided the advantage of within-subject comparison, enhancing the precision of treatment effect estimates. The findings are expected to inform clinicians about device selection for eyelid warming therapy and contribute to patient-centered recommendations in dry eye and ocular surface management.
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Being tested
- USB-Powered Warm Compress, Self-Heating Eye Mask
- Keywords
- Dry Eye, Warm Compress Therapy, Meibomian Gland Dysfunction, USB-Electrical Compress, Self-Heating Mask, Tear Film, Randomized Controlled Trial
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USB-Powered Warm CompressDevice
Also called USB Warm Compress
A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.
Self-Heating Eye MaskDevice
A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| USB-Powered Warm Compress | Experimental | Will use A USB-Powered Warm Compress constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks Receives: Device: USB-Powered Warm Compress; Device: Self-Heating Eye Mask |
| Disposable eye mask | Experimental | The group will use A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks Receives: Device: USB-Powered Warm Compress; Device: Self-Heating Eye Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Meniscus Height
To assess the tear film. The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
Measured: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
Ocular Surface Disease Index
he OSDI, which was created by the Outcomes Research Group at Allergan Inc in order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision.[5] This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life.[6] The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.[7]
The OSDI assesses quality of life measures, which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported
Measured: Baseline
tear break-up time
Non-Invasive Tear Break-Up Time (NITBUT) to assess the stability and uniformity of the tear film. The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
Measured: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
Standard Patient Evaluation of Eye Dryness
The SPEED questionnaire was designed by Korb and Blackie in order to quickly track the progression of dry eye symptoms over time.[9] This questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms. The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue. The questionnaire further assesses whether these symptoms were not problematic, tolerable, uncomfortable, bothersome, or intolerable.[10] The questionnaire also monitored diurnal and symptoms changes over 3 months.[11] Validity of the questionnaire was determined by seeing how well it was able to segregate patients based on their symptoms, relative to the OSDI questionnaire (gold standard). The resulting sensitivity and specificity were 0.90 and 0.80 respectively.[11]
Measured: Baseline at Day 1 and post intervention at Day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start5 Jan 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies 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
- Crossover
- Model description
- This study employed a randomized, two-phase crossover design, allowing each participant to serve as their own control. Participants were randomly assigned to start with either the USB-powered warm compress or the self-heating eye mask, followed by a washout period and subsequent crossover to the alternate device. This design minimized inter-individual variability and enhanced the precision of treatment comparisons by enabling within-subject analysis of both interventions.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali M Alsaqr, King Saud University
- Investigators
- Ali M ALSAQR, PHD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618169
- Sponsor's protocol ID
- IRB No. E-25-9589
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al Saqr AM, Alharbi MF, Alrumizan M, Abusharha A. USB-powered vs. self-heating warm compresses for meibomian gland dysfunction: A prospective randomized crossover clinical trial. PLoS One. 2026 Oct 13;21(10):e0360762. doi: 10.1371/journal.pone.0360762. eCollection 2026.
PubMed 42868127
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USB-Powered vs. Self-Heating Warm Compresses for Meibomian Gland Dysfunction: A Prospective Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07618169
- Acronym / sponsor ID
- IRB No. E-25-9589
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Keywords
- Dry Eye, Warm Compress Therapy, Meibomian Gland Dysfunction, USB-Electrical Compress, Self-Heating Mask, Tear Film, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 1 Jun 2026 (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.
Why was this study done?
People with Meibomian Gland Dysfunction (MGD) often have dry, irritated eyes because the tiny oil glands in their eyelids do not work properly. Applying gentle heat to the eyelids is a common way to improve the flow of oil and relieve symptoms.
This study wanted to find out whether a USB-powered warm compress or a self-heating disposable eye mask works better and feels more comfortable for patients with MGD.
Who took part?
Adults diagnosed with Meibomian Gland Dysfunction were invited to participate. Each person tried both treatments, one after the other, with a short break between them (this is called a crossover design).
What did participants do?
In one treatment phase, participants used a USB-powered warm compress for about 10 minutes per day over two weeks.
In the other phase, they used a self-heating disposable eye mask for the same amount of time.
The order of treatments was randomized to avoid bias.
Before and after each treatment, eye tests and comfort questionnaires were completed.
What did the study measure?
The main goal was to see if the treatments improved:
Tear film stability (how long the tears stay on the eye surface)
Meibomian gland function (how well the glands release oil)
Eye comfort and dryness symptoms
What were the results?
Both the USB-powered warm compress and the self-heating eye mask helped improve tear stability and comfort.
However, the USB-powered device provided slightly better results in improving gland function and patient satisfaction.
No serious side effects or discomfort were reported.
What do these results mean?
Regular eyelid warming is an effective way to manage MGD and dry eye symptoms. Both devices are safe and easy to use, but a USB-powered warm compress may offer stronger and more consistent heat for better results.
Patients and eye-care professionals can choose the device that best fits daily routines, comfort, and lifestyle.
Who conducted the study?
The study was carried out by optometrists and vision scientists specializing in ocular surface disease and dry eye therapy.
It followed ethical approval and was reviewed by an institutional research board before beginning.
Why is this study important?
MGD is one of the most common causes of dry eye disease worldwide. Understanding which home-based treatment works best helps patients, families, and clinicians make informed choices about safe and effective care options.
Detailed description
Meibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye, characterized by obstruction and altered secretion of the meibomian glands that results in tear film instability and ocular discomfort. Thermal therapy is considered a cornerstone in the management of MGD, as controlled eyelid warming can enhance lipid flow, reduce stagnation, and restore tear film quality. However, the effectiveness and convenience of commercially available warming devices may vary depending on their design and heat delivery mechanisms.
This randomized, prospective, crossover clinical trial was designed to compare the efficacy and user experience of two commonly used warming modalities: a USB-powered eyelid warming device and a disposable self-heating eye mask. Each participant received both interventions in separate treatment phases, with a washout period in between, to minimize inter-subject variability. The order of intervention was randomized, ensuring balanced exposure across participants.
The study primarily aimed to assess changes in tear film stability and meibomian gland function following each treatment. Additional measures included ocular surface comfort, tear meniscus height, and patient preference. Standardized clinical assessments were conducted before and after each intervention phase, and validated questionnaires were used to capture subjective symptoms and usability feedback. Safety and tolerability were monitored throughout all sessions.
This investigation sought to generate comparative data on the short-term outcomes of two practical home-based treatment methods for MGD. The crossover design provided the advantage of within-subject comparison, enhancing the precision of treatment effect estimates. The findings are expected to inform clinicians about device selection for eyelid warming therapy and contribute to patient-centered recommendations in dry eye and ocular surface management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employed a randomized, two-phase crossover design, allowing each participant to serve as their own control. Participants were randomly assigned to start with either the USB-powered warm compress or the self-heating eye mask, followed by a washout period and subsequent crossover to the alternate device. This design minimized inter-individual variability and enhanced the precision of treatment comparisons by enabling within-subject analysis of both interventions.
| Arm | Type | Receives |
|---|---|---|
| USB-Powered Warm Compress | Experimental | Device: USB-Powered Warm Compress, Device: Self-Heating Eye MaskWill use A USB-Powered Warm Compress constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks |
| Disposable eye mask | Experimental | Device: USB-Powered Warm Compress, Device: Self-Heating Eye MaskThe group will use A disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-40 years diagnosed with Meibomian Gland Dysfunction (MGD).
- Baseline NITBUT < 10 seconds.
- Willing to discontinue other lid therapies during the study period.
Key exclusion criteria (4 listed)
- Active ocular infection or inflammation.
- Recent ocular surgery (<3 months).
- Use of contact lenses during the study period.
- Systemic diseases affecting tear film (e.g., Sjögren's syndrome).
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 |
|---|---|---|
| USB-Powered Warm CompressAlso: USB Warm CompressA constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks. | Device | Disposable eye mask, USB-Powered Warm Compress |
| Self-Heating Eye MaskA disposable eye mask activated by air oxidation, generating warmth (~40°C) for 10 minutes daily for 2 weeks. | Device | Disposable eye mask, USB-Powered Warm Compress |
Primary outcome
Tear Meniscus Height
Time frame: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
To assess the tear film. The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
Ocular Surface Disease Index
Time frame: Baseline
he OSDI, which was created by the Outcomes Research Group at Allergan Inc in order to quickly assess the symptoms of ocular irritation in dry eye disease and how they affect functioning related to vision.[5] This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life.[6] The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.[7] The OSDI assesses quality of life measures, which aligns the questionnaire with Federal Food and Drug Administration's emphasis on utilizing patient-reported
tear break-up time
Time frame: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.
Non-Invasive Tear Break-Up Time (NITBUT) to assess the stability and uniformity of the tear film. The test was performed before and after each treatment phase to determine the improvement in tear film integrity following the application of each eyelid warming device.
Standard Patient Evaluation of Eye Dryness
Time frame: Baseline at Day 1 and post intervention at Day 5.
The SPEED questionnaire was designed by Korb and Blackie in order to quickly track the progression of dry eye symptoms over time.[9] This questionnaire gives a score from 0 to 28 that is the result of 8 items that assess frequency and severity of symptoms. The symptoms assessed include dryness, grittiness, scratchiness, irritation, burning, watering, soreness, and eye fatigue. The questionnaire further assesses whether these symptoms were not problematic, tolerable, uncomfortable, bothersome, or intolerable.[10] The questionnaire also monitored diurnal and symptoms changes over 3 months.[11] Validity of the questionnaire was determined by seeing how well it was able to segregate patients based on their symptoms, relative to the OSDI questionnaire (gold standard). The resulting sensitivity and specificity were 0.90 and 0.80 respectively.[11]
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 1 Jun 2026.
- Derived from this study: PubMed 42868127Al Saqr AM, Alharbi MF, Alrumizan M, Abusharha A. USB-powered vs. self-heating warm compresses for meibomian gland dysfunction: A prospective randomized crossover clinical trial. PLoS One. 2026 Oct 13;21(10):e0360762. doi: 10.1371/journal.pone.0360762. eCollection 2026.
- Related InfoLink provided by the sponsor.
- 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.
Ali M ALSAQR, PHD principal investigator
King Saud 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 USB-Powered Warm Compress and Self-Heating Eye Mask in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by King Saud University at 1 site in Saudi Arabia.
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 4 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 1 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 Saudi Arabia. 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?
Tear Meniscus Height (time frame: Baseline at Day 1, post intervention at Day 3 and post intervention at Day 5.). The study lists 4 primary outcomes in all. 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 NCT07618169, which also lists 1 linked publication.
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 1 Jun 2026.