Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Dry Eye Clinical Trial

— ELOM  

Official title:

Evaluation of Low-Level Light Therapy on Meibomian Glands Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05859295
• Other study ID #: STUDY00004024
• Status: Completed
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: November 11, 2023

Study information

• Verified date: December 2023
• Source: University of Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 11, 2023
• Est. primary completion date: November 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Meibomian Gland Dysfunction

Intervention

Device:
• Red Low-Level Light Therapy
Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask

Locations

Country	Name	City	State
United States	The University of Houston College of Optometry	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Houston	University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Non-invasive tear break up time	Videokeratoscope assessment of time to break up of the tear film	3 weeks
Other	Tear lipid layer thickness	Interferometric assessment of the tear film lipid layer	3 weeks
Other	Tear meniscus height	Videokeratoscope assessment of the tear meniscus	3 weeks
Primary	Meibum protein composition	Proteomic analysis of meibum collected before and after low level light therapy	3 weeks
Secondary	Meibum lipid composition	Lipidomic analysis of meibum collected before and after low level light therapy	3 weeks