Evaluation of Low-Level Light Therapy on Meibomian Glands Study (ELOM)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Meibomian Gland Dysfunction
• Intervention / Treatment: Device: Red Low-Level Light Therapy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • The University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-invasive tear break up time	Videokeratoscope assessment of time to break up of the tear film	3 weeks
Tear lipid layer thickness	Interferometric assessment of the tear film lipid layer	3 weeks
Tear meniscus height	Videokeratoscope assessment of the tear meniscus	3 weeks

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: University of Louisville
• Investigators: Principal Investigator: Eric R Ritchey, OD, PhD, The University of Houston College of Optometry

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Actual): November 11, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: May 5, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: tears; meibomian gland dysfunction; Meibomian glands
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: STUDY00004024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No