Evaluation of Low-Level Light Therapy on Meibomian Glands Study

NCT05859295 | Completed FDA Device

• 1 other identifier: STUDY00004024
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum
2. 2.Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum

Conditions

Meibomian Gland Dysfunction; Dry Eye

Keywords

Meibomian glands; meibomian gland dysfunction; tears

Outcome Measures

Primary Outcomes (1)

• Meibum protein composition

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

  3 weeks

Secondary Outcomes (1)

• Meibum lipid composition

  3 weeks

Other Outcomes (3)

• Non-invasive tear break up time

  3 weeks

• Tear lipid layer thickness

  3 weeks

• Tear meniscus height

  3 weeks

Study Arms (1)

Low-Level Light Therapy

OTHER

All subjects will receive 3 15-minute treatments of low level light therapy

Device: Red Low-Level Light Therapy

Interventions

Red Low-Level Light Therapy DEVICE

Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask

Also known as: Marco Equinox

Low-Level Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead
• University of Louisville: collaborator

Study Sites (1)

The University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes; Lacerations

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases; Wounds and Injuries

Study Officials

• Eric R Ritchey, OD, PhD

  The University of Houston College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 15, 2023
• Study Start: June 7, 2023
• Primary Completion: November 11, 2023
• Study Completion: November 11, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)