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

• Sponsor: University of Houston (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05859295
• Collaborator: University of Louisville (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.6
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Meibomian Gland Dysfunction; Dry Eye	Device: Red Low-Level Light Therapy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluation of Low-Level Light Therapy on Meibomian Glands Study
• Anticipated Study Start Date: May 12, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Meibum protein composition [3 weeks]

   Proteomic analysis of meibum collected before and after low level light therapy

Secondary Outcome Measures

1. Meibum lipid composition [3 weeks]

   Lipidomic analysis of meibum collected before and after low level light therapy

Other Outcome Measures

1. Non-invasive tear break up time [3 weeks]

   Videokeratoscope assessment of time to break up of the tear film

2. Tear lipid layer thickness [3 weeks]

   Interferometric assessment of the tear film lipid layer

3. Tear meniscus height [3 weeks]

   Videokeratoscope assessment of the tear meniscus

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Houston College of Optometry	Houston	Texas	United States	77204

Sponsors and Collaborators

• University of Houston
• University of Louisville

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric R. Ritchey, Assistant Professor, University of Houston
• ClinicalTrials.gov Identifier: NCT05859295
• Other Study ID Numbers: STUDY00004024
• First Posted: May 15, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Eric R. Ritchey, Assistant Professor, University of Houston: Meibomian glands; meibomian gland dysfunction; tears
• Additional relevant MeSH terms: Meibomian Gland Dysfunction

Study Results

No Results Posted as of May 19, 2023