Low Level Light Therapy & Skin Pigmentation

Not Applicable

Recruiting

• Conditions: Dry Eye; Meibomian Gland Dysfunction (Disorder)

• Registration Number: NCT07173530
• Lead Sponsor: University of Houston

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.

Detailed Description

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).

Study Timeline

• Study Start: 2025-06-11
• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Primary Completion: 2026-08
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The University of Houston College of Optometry; 🇺🇸 Houston, Texas, United States