What this study is
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.
What's being tested
- Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).
Intervention · DEVICE
A mask with Light Emitting Diodes wavelength 633nm will be placed over closed eyes for 15 minutes.
Study details
- Sponsor
- University of Houston
- Conditions
- Dry Eye · Meibomian Gland Dysfunction (Disorder)
- Enrolling
- 40 people
- Starts
- 2025-06-11
- Est. completion
- 2026-08
- Design
- Open-label, non-randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openThe University of Houston College of Optometry
Houston, Texas, United States
- Eric Ritchey, OD, PhD · Contact7137431933erritche@central.uh.edu
- Contacterritche@central.uh.edu
- Eric Ritchey, OD, PhD · Principal investigator
- Rachel Redfern, OD, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Houston
Study ID STUDY00005386/MOD00007330
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.