Evaluation of Low-Level Light Therapy on Meibomian Glands... | NCT05859295

Studies
Evaluation of Low-Level Light Therapy on Meibomian Glands Study

NCT05859295

Sponsor

University of Houston

Status

Completed

Last Update Posted

Dec 7, 2023Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Meibomian Gland Dysfunction
Dry Eye

Interventions

Red Low-Level Light Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2023Actual

Primary Completion Date

Nov 11, 2023Actual

Completion Date

Nov 11, 2023Actual

First Submitted Date

May 5, 2023

First Submission Date that Met QC Criteria

May 5, 2023

First Posted Date

May 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2023

Last Update Posted Date

Dec 7, 2023Actual

Name	Class
University of Louisville	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Red Low-Level Light Therapy	Device	Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask	Low-Level Light Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Meibum protein composition	Proteomic analysis of meibum collected before and after low level light therapy	3 weeks

Secondary Outcomes

Measure	Description	Time Frame
Meibum lipid composition	Lipidomic analysis of meibum collected before and after low level light therapy	3 weeks

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric R Ritchey, OD, PhD	The University of Houston College of Optometry	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Houston College of Optometry		Houston	Texas	77204	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41667355	Derived	Antwi A, Redfern R, Ritchey ER. Analysis of tear inflammatory proteins following Low-Level light therapy in dry eye disease patients. Cont Lens Anterior Eye. 2025 Apr;49(2):102629. doi: 10.1016/j.clae.2026.102629. Epub 2026 Feb 9.

ID	Term
D000080343	Meibomian Gland Dysfunction
D015352	Dry Eye Syndromes
D022125	Lacerations

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases
D007766	Lacrimal Apparatus Diseases
D014947	Wounds and Injuries