Recruiting

LLLT

Sponsor:

University of Houston

Code:

NCT07173530

Conditions

Dry Eye

Meibomian Gland Dysfunction (Disorder)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Dry Eye

Meibomian Gland Dysfunction (Disorder)

Study ID

NCT07173530

Start date

Jun 11, 2025

Status verified date

Jul, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fitzpatrick skin tone I-IV

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

experimental: Fitzpatrick skin tone V-VI

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

Interventions

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

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

Primary outcome measure

  • Eyelid temperature [ Time Frame: Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit. ]

Central Contacts and Locations

Central contacts

Eric Ritchey, OD, PhD

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

Rachel Redfern, OD, PhD

713-743-1943rredfern@uh.edu

Locations

The University of Houston College of Optometry

Recruiting

Houston, Texas, United States, 77204

Contacts

Eric Ritchey, OD, PhD

7137431933erritche@central.uh.edu

erritche@central.uh.edu

Principal Investigator:

Eric Ritchey, OD, PhD

More Information

Sponsor

University of Houston

Last update posted

Sep 15, 2025

Last verified

Jul, 2025

Keywords

  • Dry Eye
  • Meibomian Gland
  • LLLT
  • Low-level light therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2025-09-15.