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

Primary Purpose

Meibomian Gland Dysfunction, Dry Eye

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Red Low-Level Light Therapy
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Meibomian Gland Dysfunction focused on measuring Meibomian glands, meibomian gland dysfunction, tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Houston College of OptometryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Low-Level Light Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 5, 2023
Last Updated
June 20, 2023
Sponsor
University of Houston
Collaborators
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT05859295
Brief Title
Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Acronym
ELOM
Official Title
Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston
Collaborators
University of Louisville

4. Oversight

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
Data Monitoring Committee
No

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction, Dry Eye
Keywords
Meibomian glands, meibomian gland dysfunction, tears

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-Level Light Therapy
Arm Type
Other
Arm Description
All subjects will receive 3 15-minute treatments of low level light therapy
Intervention Type
Device
Intervention Name(s)
Red Low-Level Light Therapy
Other Intervention Name(s)
Marco Equinox
Intervention Description
Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask
Primary Outcome Measure Information:
Title
Meibum protein composition
Description
Proteomic analysis of meibum collected before and after low level light therapy
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Meibum lipid composition
Description
Lipidomic analysis of meibum collected before and after low level light therapy
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
Non-invasive tear break up time
Description
Videokeratoscope assessment of time to break up of the tear film
Time Frame
3 weeks
Title
Tear lipid layer thickness
Description
Interferometric assessment of the tear film lipid layer
Time Frame
3 weeks
Title
Tear meniscus height
Description
Videokeratoscope assessment of the tear meniscus
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric R Ritchey, OD, PhD
Phone
7137431933
Email
erritche@central.uh.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Antoinette Antwi, OD
Email
aantwi@cougarnet.uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric R Ritchey, OD, PhD
Organizational Affiliation
The University of Houston College of Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Houston College of Optometry
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric R Ritchey, OD, PhD
Phone
713-743-1933
Email
erritche@central.uh.edu
First Name & Middle Initial & Last Name & Degree
Antoinette Antwi, OD
Email
aantwi@cougarnet.uh.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Low-Level Light Therapy on Meibomian Glands Study

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