Treating Meibomian Gland Disease in a Pediatric Population

NCT07229001 | Enrolling By Invitation

• 1 other identifier: 22023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye Disease, Meibomian Gland Disease

Keywords

Dry eye disease, Meibomian Gland Disease

Outcome Measures

Primary Outcomes (2)

• Change in MG

  atrophy score

  1 months

• MG score

  atropine score

  1 month

Study Arms (2)

warm compress and artificial tear

PLACEBO COMPARATOR

warm compress and artificial tear

Other: warm compress and artificial tear

LLLT

EXPERIMENTAL

LLLT+ warm compress and artificial tear

Other: Low level light treatment

Interventions

Low level light treatment OTHER

, 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.

LLLT

warm compress and artificial tear OTHER

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

warm compress and artificial tear

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• subjects with severe MGD

You may not qualify if:

• 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

Sponsors & Collaborators

• Illinois College of Optometry: lead

Study Sites (1)

Illinois College of Optometry

Chicago, Illinois, 60608, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Interventions

Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

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

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)