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Enrolling by invitationNCT07229001LLLT in PedsUpdated Nov 14, 2025

Treating Meibomian Gland Disease in a Pediatric Population

An interventional study of Low level light treatment and warm compress and artificial tear in Dry Eye Disease, Meibomian Gland Disease, sponsored by Illinois College of Optometry. Enrolling by invitation at 1 site in United States. Open to participants aged 6 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by Illinois College of Optometry · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Oct 2024, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
6 Years to 18 Years
Sex
All
01

Study summary

Dry Eye Disease (DED) is commonly encountered among eye care professionals. DED is a disease of the tears and ocular surface that is multi-factorial resulting in a wide range of symptoms and signs with potentially damaging effects. As technology continues to evolve and as digital devices become more available in social, work environments, and in school settings, patients are increasingly complaining of ocular discomfort and fluctuations in their vision.

In order to diagnose DED which encompasses Meibomian gland dysfunction (MGD), a detailed case history of \patients' symptoms along with imaging to investigate the amount of disease present in their eyes is needed. A customized questionnaire and the Keratograph meibographer will allow for a subjective and objective investigation of dry eye disease in patients. Artificial tears and warm compress are traditional methods used to treat DED. However, many patients continue to have progression of disease. The Marco Equinox Low Level Light Therapy (LLLT) utilizes a LED mask to apply red light to the periorbital and cheekbone regions of the face, which effectively normalizes meibomian gland function. This is a non-invasive treatment of both the upper and lower eyelids, which does not require a gel application. Treatment of both eyes takes approximately 15 minutes. In the clinical studies that have been published, lipid layer interference pattern, non-invasive tear break up time, lissamine green conjunctival staining, Schirmer's test, and upper meibography scores showed significant improvement by 4 weeks after the start of treatment with LLLT. To our knowledge, this has not been studied in the pediatric population, but the disease process is the same. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to traditional treatment (warm compress and artificial tear) only in children.

Read the detailed description

The clinical diagnosis of Dry Eye Disease is often made using a combination of subjective symptoms and clinical signs. During early development of DED, patients may be asymptomatic. If asymptomatic, the diagnosis of DED is only detectable by the presence of clinical signs. Advanced DED can be debilitating as it can lead to multiple complications including increasing the risk of eye infections and destruction of ocular tissue which eventually causes a loss of functional visual acuity1-3.

Symptoms of dry eye may include ocular itching, burning, redness, irritation, soreness and or edema of the eyelids, foreign body sensation, tearing, fluctuating vision, and contact lens intolerance. The signs of ocular surface damage includes staining to the bulbar conjunctiva and cornea, reduced tear-break-up-time, decreased tear production, and decreased tear quaaulity. Several questionnaires have been reviewed5-6 to assess symptoms of ocular surface disease and dry eye. The Ocular Surface Disease Index (OSDI)5 assesses vision-related function, ocular symptoms, and environmental triggers resulting from dry eye where the goal of the Dry Eye Questionnaire 5 (DEQ-5) is to identify patients with keratoconjunctivitis sicca from those without the condition by asking about the frequency of the feeling of eye dryness. This may be more appropriate to use in the pediatric population as they may not be able to identify with the feeling of dryness, but they should be able to understand 'discomfort' or 'uncomfortable'. While not validated in the pediatric population and regardless of their diagnostic sensitivity for dry eye, standardized questionnaires help assess subjective changes of the patient's symptoms in response to treatment.

Meibomian gland dysfunction can result from a variety of factors, including but not limited to incomplete blinking due to the gland not being able to express a clear lipid layer. This can result in inadequate distribution of the lipid component of the tear layer thereby disrupting adherence of the tears to the eye and thus causing patients to experience the common symptom of "dry eyes." 1,3,4 Once atrophy of the gland occurs, the damage cannot be reversed. Therefore, it is crucial for these patients to maintain healthy tear films and meibomian glands so they don't experience a decrease in visual acuity that can interfere with activities of daily life.

There are several factors which have been proposed to decrease the quality the tear layer and affect the viability of the meibomian glands, and they will be assessed during this study via questionnaires. The one of main interest, particularly in the pediatric population is digital device use. Patient usage of digital devices including: handheld tablets, smart phones, laptops, and computers are increasing as new technology develops and as social and work environments adapt to these technological changes. With the increase in usage of digital devices, eye care practitioners have noted an increase in dry eye signs and symptoms. The potential adverse effect of increased digital device usage may interfere with work performance, productivity, and quality of life.7-9

High levels of mild meibomian gland atrophy have been reported in the pediatric population. This may be due to increased digital device use and near demands of schoolwork. Subsequently, we should be examining young patients for meibomian gland atrophy and dysfunction as early as possible as it may have implications for future development of dry eye disease and complications. Artificial tears and warm compress have been the traditional treatments for DED. Recently, LLLT has been confirmed to produced significant improvements in meibomian gland function and symptoms.10 However, it has not been tested in children. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to using warm compress and artificial tear only in children.

02

Conditions studied

  • Dry Eye Disease, Meibomian Gland Disease

Keywords

  • Dry eye disease, Meibomian Gland Disease
03

In context

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

This study's planned enrollment of 15 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Illinois College of Optometry is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • subjects with severe MGD

Exclusion criteria

Exclusion Criteria:

  • i. Thyroid disease ii. disease iii. Diabetes iv. History of ocular surgery other than refractive surgery v. Disfiguring eye trauma vi. Active infections or severe allergic conjunctivitis vii. Currently pregnant or nursing viii. Epilepsy vii.ix. Migraine
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Placebo comparator
    warm compress and artificial tear

    warm compress and artificial tear

    Other: warm compress and artificial tear

  • Experimental
    LLLT

    LLLT+ warm compress and artificial tear

    Other: Low level light treatment

Interventions

  • OtherLow level light treatment

    , LLLT has been confirmed to produced significant improvements in meibomian gland function and symptoms. However, it has not been tested in children. Thus, the study purpose is to determine the treatment effect of LLLT on MGD and DED comparing to using warm compress and artificial tear only in children.

  • Otherwarm compress and artificial tear

    Artificial tears and warm compress have been the traditional treatments for DED.

06

What researchers measure

Primary outcomes

  1. Change in MG

    atrophy score

    Time frame: 1 months

  2. MG score

    atropine score

    Time frame: 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07229001
Lead sponsor
Illinois College of Optometry
Responsible party
Yi Pang (professor, Illinois College of Optometry) — Principal investigator
First posted
Nov 14, 2025
Start date
Oct 1, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Nov 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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