Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Study Overview
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Brief Summary
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The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are: Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.

Detailed Description
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Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.

Official Title
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Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Conditions
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Meibomian Gland Dysfunction, Dry Eye

Intervention / Treatment
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* Device: Red Low-Level Light Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older at enrollment Individuals with mild to moderate meibomian gland dysfunction based on clinical signs, e.g., meibum quality score of 1-3, meibography score of 1, 2, or 3 on the Pult Meiboscale, non-invasive 1st tear break up time of 10 seconds or less, or an Ocular Surface Disease Index (OSDI) score of 13 to 32 points Exclusion Criteria: History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome) History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level light therapy (LLLT) within the last 12 months Use of photosensitizing medications Pregnant and/or lactating females Pigmented lesions, tattoos, or skin cancer in the periocular region

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low-Level Light Therapy<br>All subjects will receive 3 15-minute treatments of low level light therapy | Device: Red Low-Level Light Therapy<br>* Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask<br>* Other names: Marco Equinox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibum protein composition | Proteomic analysis of meibum collected before and after low level light therapy | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibum lipid composition | Lipidomic analysis of meibum collected before and after low level light therapy | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tears, Meibomian glands, meibomian gland dysfunction