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Dry Eye Disease, Meibomian Gland DiseaseLLLT in PedsNCT07229001

Treating Meibomian Gland Disease in a Pediatric Population

A study testing Low level light treatment and warm compress and artificial tear in people with Dry Eye Disease, Meibomian Gland Disease, run by Illinois College of Optometry at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 6 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease, Meibomian Gland Disease
What is being tested?
Low level light treatment and warm compress and artificial tear
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to 30 Dec 2026
Phase
Interventional

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 6 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • subjects with severe MGD

Who cannot join

  • i. Thyroid disease ii. Autoimmune 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Illinois College of Optometry

    Chicago, Illinois, 60608

Other trials in United States

About this study

Official title: A Randomized Clinical Trial of Treating Meibomian Gland Disease in a Pediatric Population

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.

Being tested
Low level light treatment, warm compress and artificial tear
Keywords
Dry eye disease, Meibomian Gland Disease
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.

  • Low level light treatmentOther

    , 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.

  • warm compress and artificial tearOther

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

Study groups in NCT07229001
Study groupRoleWhat they receive
warm compress and artificial tearPlacebo comparatorwarm compress and artificial tear
Receives: Other: warm compress and artificial tear
LLLTExperimentalLLLT+ warm compress and artificial tear
Receives: Other: Low level light treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in MG

    atrophy score

    Measured: 1 months

  2. MG score

    atropine score

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2025
  2. Study start1 Oct 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07229001
Sponsor's protocol ID
22023
Acronym
LLLT in Peds
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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