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NCT Number: NCT07173530

Low Level Light Therapy & Skin Pigmentation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Houston College of Optometry

Houston, Texas, 77204, United States

Location status: Recruiting

Location contact

Eric Ritchey, OD, PhD

CONTACT

[email protected]

7137431933

Eric Ritchey, OD, PhD

PRINCIPAL_INVESTIGATOR

Rachel Redfern, OD, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

The primary objective of the study is to determine if there is a difference in the thermal effect of low-level light therapy (LLLT) in individuals with different skin pigmentation (Fitzpatrick skin type I-IV verses Fitzpatrick skin type V-VI) using a clinically available 633nm LLLT system, the Epi-C-Plus (Espansione group, Bologna, Italy).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Eyelid temperature

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

Secondary outcomes

  1. Ocular Surface Disease Index Questionnaire

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

  2. Tear break up time

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

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Ritchey, OD, PhD

CONTACT

[email protected]

713-743-1933

Rachel Redfern, OD, PhD

CONTACT

[email protected]

713-743-1943

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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