Low-Level Light Therapy for Dry Eye Syndrome

Overseen By Eric Ritchey, OD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Houston

Must not be taking: Photosensitizing medications

Disqualifiers: Anterior segment pathology, Sjogren's, corneal surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1-2 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how low-level light therapy (LLLT) affects eyelid temperature in individuals with dry eye syndrome and varying skin tones. Participants will undergo three short LLLT sessions over one to two weeks. The trial seeks individuals with symptoms of meibomian gland disease, a condition affecting the oil glands in the eyelids, who frequently experience dry eyes. Participants must not have recently undergone certain eye treatments or surgeries and should not have active eye infections. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new insights and treatments for dry eye syndrome.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used photosensitizing medications in the last 30 days.

What prior data suggests that low-level light therapy is safe for dry eye syndrome?

Research has shown that low-level light therapy (LLLT) is generally safe and gentle on the skin. It uses red light to activate cells without causing harm or heat. Past studies have not reported major serious side effects with LLLT. It's important to note that other light treatments, such as intense pulsed light, can cause side effects like redness and swelling, but these differ from LLLT. Overall, LLLT appears to be a safe option for treating dry eye symptoms, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Low-Level Light Therapy (LLLT) is unique because it offers a non-invasive alternative to traditional treatments for Dry Eye Syndrome, such as artificial tears, anti-inflammatory medications, and punctal plugs. Unlike these methods, LLLT uses specific wavelengths of light to stimulate cellular activity, potentially enhancing the eye's natural healing process without the use of drugs or surgery. Researchers are excited about LLLT because it could provide a safe and effective treatment across varying skin tones, suggesting wider applicability and accessibility for patients with diverse needs.

What evidence suggests that low-level light therapy is effective for dry eye syndrome?

Studies have shown that low-level light therapy (LLLT) can alleviate dry eye symptoms. One study demonstrated that using LED-LLLT improved the stability of the tear film, enhancing eye comfort. Another study found that just three sessions of LLLT significantly reduced dry eye symptoms. This therapy improves the function of the meibomian glands, which help maintain eye moisture. Overall, research suggests that LLLT could effectively manage dry eye symptoms. Participants in this trial will receive LLLT, with treatment arms stratified by Fitzpatrick skin tone to assess its effectiveness across different skin types. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with dry eye conditions like Dry Eye Syndrome, Meibomian Gland Dysfunction, and Blepharitis. It's specifically looking at how skin pigmentation affects the outcome of low-level light therapy on eyelid temperature.

Inclusion Criteria

Ability to read and understand the study informed consent in English

I am 18 years old or older.

I have been diagnosed with MGD based on specific eye tests and symptoms.

Exclusion Criteria

History of LipiFlow, iLux, Meiboflow, IPL or LLLT within the last 12 months

Pregnant and/or lactating females, by self-report

I do not have an active eye infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive low-level light therapy (LLLT) with 3 fifteen-minute sessions over 7 to 14 days

1-2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low Level Light Therapy

Trial Overview The study tests if three 15-minute sessions using LED lights (633nm wavelength) can affect eyelid temperature in people with varying skin tones who have certain dry eye conditions over about one to two weeks.

How Is the Trial Designed?

Group I: Fitzpatrick skin tone V-VI Experimental Treatment 1 Intervention

Individuals with skin tones V-Vi on the Fitzpatrick scale will receive low-level light therapy

Group II: Fitzpatrick skin tone I-IV Experimental Treatment 1 Intervention

Individuals with skin tones I-IV on the Fitzpatrick scale will receive low-level light therapy

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials

155

Recruited

48,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8897458/

Effect of low-level light therapy in patients with dry eye Our study demonstrated that LED-LLLT at a dose of ≈ 60 J/cm2 per treatment session effected improvements in the signs and symptoms of dry eye.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1367048425000906

Low-level light therapy alone versus combination ... Symptom frequency rated with the Symptom Assessment Questionnaire in Dry Eye improved from baseline to final follow-up with combined therapy ( ...

3. mayoclinic.org mayoclinic.org/medical-professionals/ophthalmology/news/intense-pulsed-light-for-treatment-of-dry-eye-disease/mac-20430229

Intense pulsed light for treatment of dry eye disease 8 patients (23%) had a ≥ 50% decrease in SPEED2 scores. · 23 patients (66%) had a 1% to 49% decrease in SPEED2. · 1 patient (3%) had no change in ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/opo.13371?af=R

Effect of low‐level light therapy in individuals with dry eye ... After three treatments of LLLT within a span of 3 weeks, tear film stability and ocular comfort improved significantly in participants with mild ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07067294

Effect of Low-Level Light Therapy on Ocular Surface ... The LLLT protocol is designed to photobiomodulate eyelid and periocular tissues to enhance meibomian gland function and reduce subclinical inflammation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11334916/

Tolerability of Current Treatments for Dry Eye Disease Low-level light therapy (LLLT) specifically uses red-light wavelengths, and this allows for atraumatic and athermal cellular photobioactivation.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1542012420300999

Intense pulsed light treatment in meibomian gland ... The adverse effects included blistering, cheek swelling, conjunctival cyst, floaters, hair loss at the brow and forehead, light sensitivity, and face redness.

8. emedicine.medscape.com emedicine.medscape.com/article/1210417-overview

Dry Eye Disease (Keratoconjunctivitis Sicca) Intense pulsed light therapy. Intranasal tear neurostimulator ... Safety and Efficacy of Intranasal Neurostimulation for Dry Eye Disease.

9. aetna.com aetna.com/cpb/medical/data/400_499/0457.html

Dry Eyes - Medical Clinical Policy Bulletins Aetna considers the following interventions for the treatment of dry eyes experimental, investigational, or unproven (not an all-inclusive list).

10. clinicaltrials.gov clinicaltrials.gov/study/NCT06392438

Cyclosporine and Intense Pulsed Light for Dry Eye in ... In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact ...