Dry EyeNCT07173530
Low Level Light Therapy & Skin Pigmentation
A study testing Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus). in people with Dry Eye and Meibomian Gland Dysfunction (Disorder), run by University of Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction (Disorder)
- What is being tested?
- Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Houston College of Optometry
Houston, Texas, 77204
Eric Ritchey, OD, PhD, 7137431933, erritche@central.uh.edu
erritche@central.uh.edu
About this study
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.
Read the 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).
- Conditions
- Dry Eye, Meibomian Gland Dysfunction (Disorder)
- Being tested
- Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).
- Keywords
- Dry Eye, Meibomian Gland, LLLT, Low-level light therapy
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fitzpatrick skin tone I-IV | Experimental | Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy Receives: 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 Receives: Device: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eyelid temperature
Measured: 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
Measured: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.
Tear break up time
Measured: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start11 Jun 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric R. Ritchey, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173530
- Sponsor's protocol ID
- STUDY00005386/MOD00007330
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level Light Therapy & Skin Pigmentation
- ClinicalTrials.gov ID
- NCT07173530
- Acronym / sponsor ID
- STUDY00005386/MOD00007330
- Conditions
- Dry Eye, Meibomian Gland Dysfunction (Disorder)
- Keywords
- Dry Eye, Meibomian Gland, LLLT, Low-level light therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitzpatrick skin tone I-IV | Experimental | Device: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy |
| Fitzpatrick skin tone V-VI | Experimental | Device: Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus).Individuals with skin tones V-Vi on the Fitzpatrick scale will receive low-level light therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Fitzpatrick skin tone I-IV, Fitzpatrick skin tone V-VI |
Primary outcome
Eyelid temperature
Time frame: Eyelid temperature will be measured before and after 15 minutes of low-level light therapy at the baseline visit.
2 secondary outcomes
Ocular Surface Disease Index Questionnaire
Time frame: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.
Tear break up time
Time frame: After 3 low-level light therapy treatment sessions through study completion, an average of 1 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three 15-minute low-level light therapy sessions using Light Emitting Diodes of wavelength 633nm (Essilor epi-c plus). in people with Dry Eye and Meibomian Gland Dysfunction (Disorder), run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Ritchey, OD, PhD (713-743-1933, erritche@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.