Clinical trial NCT05859295: Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Official title: Evaluation of Low-Level Light Therapy on Meibomian Glands Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Keywords: Meibomian glands
meibomian gland dysfunction
tears
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: University of Louisville
First posted: 2023-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

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

Primary outcomes:
measure: Meibum protein composition
timeFrame: 3 weeks
Secondary outcomes:
measure: Meibum lipid composition
timeFrame: 3 weeks
Other outcomes:
measure: Non-invasive tear break up time
timeFrame: 3 weeks
measure: Tear lipid layer thickness
timeFrame: 3 weeks
measure: Tear meniscus height
timeFrame: 3 weeks
Locations:
city: Houston
country: United States
facility: The University of Houston College of Optometry
state: Texas
Study officials:
affiliation: The University of Houston College of Optometry
name: Eric R Ritchey, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: