Meibomian Gland DysfunctionELOMNCT05859295
Evaluation of Low-Level Light Therapy on Meibomian Glands Study
A study testing Red Low-Level Light Therapy in people with Meibomian Gland Dysfunction and Dry Eye, run by University of Houston at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are: 1. Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction, Dry Eye
- What is being tested?
- Red Low-Level Light Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to 11 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 years or older at enrollment
- Individuals with mild to moderate meibomian gland dysfunction based on clinical signs, e.g., meibum quality score of 1-3, 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 of 13 to 32 points
Who cannot join
- History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
- History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months
- History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level light therapy (LLLT) within the last 12 months
- Use of photosensitizing medications
- Pregnant and/or lactating females
- Pigmented lesions, tattoos, or skin cancer in the periocular region
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Houston College of Optometry
Houston, Texas, 77204
About this study
The goal of this clinical trial is to examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are:
- Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum
- Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum
Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.
Read the detailed description
Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Being tested
- Red Low-Level Light Therapy
- Keywords
- Meibomian glands, meibomian gland dysfunction, tears
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red Low-Level Light TherapyDevice
Also called Marco Equinox
Visible red light (633nm) projected onto the face using an light emitting diode (LED) mask
| Study group | Role | What they receive |
|---|---|---|
| Low-Level Light Therapy | Other | All subjects will receive 3 15-minute treatments of low level light therapy Receives: Device: Red Low-Level Light Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibum protein composition
Proteomic analysis of meibum collected before and after low level light therapy
Measured: 3 weeks
Secondary outcomes (1)
Meibum lipid composition
Lipidomic analysis of meibum collected before and after low level light therapy
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start7 Jun 2023
- Primary completion11 Nov 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville
- Responsible party
- Principal investigator, Eric R. Ritchey, University of Houston
- Investigators
- Eric R Ritchey, OD, PhD, Principal investigator, The University of Houston College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859295
- Sponsor's protocol ID
- STUDY00004024
- Acronym
- ELOM
- Status last verified
- Dec 2023
- First submitted
- 5 May 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Antwi A, Redfern R, Ritchey ER. Analysis of tear inflammatory proteins following Low-Level light therapy in dry eye disease patients. Cont Lens Anterior Eye. 2025 Apr;49(2):102629. doi: 10.1016/j.clae.2026.102629. Epub 2026 Feb 9.
PubMed 41667355
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Low-Level Light Therapy on Meibomian Glands Study
- ClinicalTrials.gov ID
- NCT05859295
- Acronym / sponsor ID
- ELOM / STUDY00004024
- Conditions
- Meibomian Gland Dysfunction, Dry Eye
- Keywords
- Meibomian glands, meibomian gland dysfunction, tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- University of Louisville
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 11 Nov 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 15 May 2023 (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 examine the effect of low-level light therapy (LLLT) on meibomian gland dysfunction and dry eye disease. The main questions it aims to answer are:
- Does low-level light therapy reduce levels of pro-inflammatory proteins in meibum
- Does low-level light therapy increase the ratio of non-polar lipids to polar lipids in meibum
Participants will receive 3 15-minute sessions of low-level light therapy. Meibum will be collected before the first treatment and after the final treatment.
Detailed description
Low-level light therapy (LLLT) is a treatment for meibomian gland dysfunction. The proposed mechanism of action is photobiomodulation of cells leading to improved adenosine triphosphate synthesis, reduction of reactive oxygen species in oxidatively-stressed cells, and the activation of transcription factors involved in cellular proliferation, migration and survival. Understanding of how low-level light therapy based therapy alters meibomian gland function is poor. This study will examine the effect of low-level light therapy on individuals with meibomian gland dysfunction. Eligible subjects will receive 15 minutes of low-level light therapy per week over a 3 week period. Meibum collected prior to treatment will be compared to meibum collected after 3 treatment sessions for alteration in protein and lipid composition.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Level Light Therapy | Other | Device: Red Low-Level Light TherapyAll subjects will receive 3 15-minute treatments of 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 (2 listed)
- Age 18 years or older at enrollment
- Individuals with mild to moderate meibomian gland dysfunction based on clinical signs, e.g., meibum quality score of 1-3, 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 of 13 to 32 points
Key exclusion criteria (6 listed)
- History of systemic disease associated with aqueous-deficient dry eye disease (e.g., Sjogren's syndrome)
- History of corneal surgery, refractive surgery, eyelid surgery or ocular trauma within 6 months
- History of LipiFlow, iLux, Meiboflow, Intense Pulsed Light (IPL) or low level light therapy (LLLT) within the last 12 months
- Use of photosensitizing medications
- Pregnant and/or lactating females
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 |
|---|---|---|
| Red Low-Level Light TherapyAlso: Marco EquinoxVisible red light (633nm) projected onto the face using an light emitting diode (LED) mask | Device | Low-Level Light Therapy |
Primary outcome
Meibum protein composition
Time frame: 3 weeks
Proteomic analysis of meibum collected before and after low level light therapy
1 secondary outcome
Meibum lipid composition
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Derived from this study: PubMed 41667355Antwi A, Redfern R, Ritchey ER. Analysis of tear inflammatory proteins following Low-Level light therapy in dry eye disease patients. Cont Lens Anterior Eye. 2025 Apr;49(2):102629. doi: 10.1016/j.clae.2026.102629. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eric R Ritchey, OD, PhD principal investigator
The University of Houston College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Low-Level Light Therapy in people with Meibomian Gland Dysfunction and Dry Eye, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 7 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Meibum protein composition (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859295, which also lists 1 linked publication.
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 7 Dec 2023.