Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Not Applicable

Completed

• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Interventions: Device: Red Low-Level Light Therapy

• Registration Number: NCT05859295
• Lead Sponsor: University of Houston

Brief Summary

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:

1. Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum

2. 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

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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-15
• Study Start: 2023-06-07
• Primary Completion: 2023-11-11
• Study Completion: 2023-11-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-Level Light Therapy	Red Low-Level Light Therapy	All subjects will receive 3 15-minute treatments of low level light therapy

Primary Outcome Measures

Name	Time	Method
Meibum protein composition	3 weeks	Proteomic analysis of meibum collected before and after low level light therapy

Secondary Outcome Measures

Name	Time	Method
Meibum lipid composition	3 weeks	Lipidomic analysis of meibum collected before and after low level light therapy

Trial Locations

Locations (1)

The University of Houston College of Optometry; 🇺🇸 Houston, Texas, United States