Comparative Effects of USB-Powered Warm Compress and Self-Heating Eye Mask in the Management of Meibomian Gland Dysfunction

NCT07618169 | Completed

• 1 other identifier: IRB No. E-25-9589
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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.\[11\]

  Baseline at Day 1 and post intervention at Day 5.

Study Arms (2)

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

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

Device: USB-Powered Warm Compress; Device: Self-Heating Eye Mask

Interventions

USB-Powered Warm Compress DEVICE

A constant-temperature device delivering controlled eyelid warming (≈40°C) for 10 minutes daily for 2 weeks.

Also known as: USB Warm Compress

Disposable eye mask; USB-Powered Warm Compress

Self-Heating Eye Mask DEVICE

A disposable eye mask activated by air oxidation, generating warmth (\~40°C) for 10 minutes daily for 2 weeks.

Disposable eye mask; USB-Powered Warm Compress

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, Central Region, RIAYDH 113, Saudi Arabia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Officials

• Ali M ALSAQR, PHD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 1, 2026
• Study Start: January 5, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)