NCT07173530

Brief Summary

The goal of this clinical trial is to determine if there is a difference in eyelid temperature after low-level light therapy (LLLT) in individuals with different amounts of skin pigmentation and dry eye/meibomian gland disease. Participants will have 3 fifteen minute in office LLLT therapy sessions over a period of approximately 7 to 14 days.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Jun 2025Aug 2026

Study Start

First participant enrolled

June 11, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 15, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

July 7, 2025

Last Update Submit

September 8, 2025

Conditions

Dry EyeMeibomian Gland Dysfunction (Disorder)

Keywords

Dry EyeMeibomian GlandLLLTLow-level light therapy

Outcome Measures

Primary Outcomes (1)

  • Eyelid temperature

    Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit.

Secondary Outcomes (2)

  • Ocular Surface Disease Index Questionnaire

    After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.

  • Tear break up time

    After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.

Study Arms (2)

Fitzpatrick skin tone I-IV

EXPERIMENTAL

Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy

Device: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

Fitzpatrick skin tone V-VI

EXPERIMENTAL

Individuals with skin tones V-Vi on the Fitzpatrick scale will receive low-level light therapy

Device: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).

Interventions

Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).DEVICE

A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.

Fitzpatrick skin tone I-IVFitzpatrick skin tone V-VI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ability to read and understand the study informed consent in English
  • Age 18 years or older at enrollment
  • Individuals with MGD based on one or more of the following clinical signs/symptoms, e.g., meibum quality score of 1-3 (Bron et al.), 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 greater than 12 points.

You may not qualify if:

  • Active anterior segment pathology (e.g., bacterial conjunctivitis, microbial keratitis)
  • History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
  • History of corneal surgery, refractive surgery, or eyelid surgery within 6 months
  • History of corneal ectasia (e.g. keratoconus, Pellucid marginal degeneration)
  • History of ocular trauma within 6 months
  • History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months
  • Habitual use of photosensitizing medications within the last 30 days
  • Pregnant and/or lactating females, by self-report
  • Pigmented lesions, tattoos, or skin cancer in the periocular region
  • Unwilling to have eyes photographed or video recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Houston College of Optometry

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye SyndromesMeibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesEyelid Diseases

Central Study Contacts

Eric Ritchey, OD, PhD

CONTACT

713-743-1933erritche@central.uh.edu

Rachel Redfern, OD, PhD

CONTACT

713-743-1943rredfern@uh.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 7, 2025

First Posted

September 15, 2025

Study Start

June 11, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

September 15, 2025

Record last verified: 2025-07

Locations

US(1)