Light Therapy + MGX for Dry Eye Disease

Not currently recruiting at 2 trial locations

Overseen By Konika Patel Schallen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Candela Corporation

Must not be taking: Photosensitizing drugs

Disqualifiers: Contact lenses, Ocular surgery, Uncontrolled infections, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effects of light therapy combined with Meibomian Gland Expression (MGX) to treat Dry Eye Disease caused by Meibomian Gland Dysfunction. Participants will receive either real light therapy sessions using the Nordlys system or a sham treatment with the device turned off. It is best suited for individuals with persistent dry eyes and specific tear and gland function levels. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance treatment options for Dry Eye Disease.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications that cause dryness, like isotretinoin and antihistamines, at least 1 month before the study starts. If you're taking prescription eye drops for dry eye, you'll need to stop using them 7 days before the study. Other medications may also need to be stopped or adjusted, so it's best to discuss your specific situation with the study team.

What prior data suggests that the Nordlys SWT IPL and MGX treatments are safe for dry eye disease?

Research has shown that using intense pulsed light (IPL) with meibomian gland expression (MGX) is generally safe for treating dry eye. Studies indicate that patients tolerate these treatments well, with few reports of serious side effects. Most people experience mild discomfort, such as a warming sensation, during IPL treatment. This combination of treatments has shown promise in easing dry eye symptoms, leading to more comfortable eyes. For those considering joining a study, this information suggests the treatments are safe. However, discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of Nordlys SWT IPL combined with Meibomian Gland Expression (MGX) for treating dry eye disease because it introduces a unique approach. Unlike most treatments that focus on lubricating the eyes or reducing inflammation, this method targets the root cause by improving the function of meibomian glands, which produce the oily layer of tears. The Nordlys SWT IPL uses specific light wavelengths to stimulate these glands, potentially leading to longer-lasting relief and fewer side effects. This new mechanism offers hope for more effective management of dry eye symptoms compared to standard treatments like artificial tears and anti-inflammatory medications.

What evidence suggests that this trial's treatments could be effective for dry eye disease?

Research shows that intense pulsed light (IPL) therapy, such as the Nordlys SWT IPL studied in this trial, effectively treats dry eye disease caused by oil gland issues in the eyelids. In earlier studies, patients who received IPL treatment experienced improvements in both symptoms and signs of dry eye. The therapy uses light pulses to open and clear blocked oil glands in the eyes, helping restore normal tear production and reducing dryness. In this trial, one group of participants will receive the Nordlys SWT IPL treatment combined with meibomian gland expression (MGX), a technique that gently squeezes out blockages in these glands. This combination has shown promising results in improving eye comfort and function. Another group will receive a sham treatment with MGX to compare the outcomes. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

Adults aged 18-75 with dry eye disease due to meibomian gland dysfunction can join this trial. They should have a certain level of dryness and gland function, be willing to follow the study schedule, consent to photos for research use, and not wear contact lenses during the study. People with recent eye surgeries or infections, skin cancer in the treatment area, uncontrolled diseases, light-sensitive conditions or treatments are excluded.

Inclusion Criteria

You are willing to sign a consent form indicating you understand the study requirements.

You consent to having your treated areas photographed and used for evaluation, publication, presentation, or promotional purposes.

You reported a score of 23 or higher on the OSDI questionnaire.

Exclusion Criteria

Current use of punctal plugs

Over exposure to sun, within 4 weeks prior to screening

I have an eyelid condition that affects its function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive four IPL treatments and meibomian gland expression at 2-week intervals

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Meibomian Gland Expression (MGX)
• Nordlys SWT IPL

Trial Overview The clinical trial is testing Nordlys SWT IPL technology against a sham (fake) treatment for improving dry eye symptoms caused by meibomian gland dysfunction. Participants will also undergo Meibomian Gland Expression (MGX), which is a procedure to clear blocked glands.

How Is the Trial Designed?

Group I: Experimental: Nordlys SWT IPL Experimental Treatment 2 Interventions

Subjects will receive up to four study Nordlys SWT IPL treatments and MGX

Group II: Control Group: Sham Treatment Placebo Group 2 Interventions

Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX

Meibomian Gland Expression (MGX) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Meibomian Gland Expression for:

• Dry Eye Disease due to Meibomian Gland Dysfunction
• Blepharitis

Approved in European Union as Meibomian Gland Expression for:

• Dry Eye Disease due to Meibomian Gland Dysfunction
• Blepharitis
• Chalazion

Approved in Canada as Meibomian Gland Expression for:

• Dry Eye Disease due to Meibomian Gland Dysfunction
• Blepharitis

Who Is Running the Clinical Trial?

Candela Corporation

Lead Sponsor

Trials

22

Recruited

2,200+

Published Research Related to This Trial

In a study of 40 subjects with moderate to severe meibomian gland dysfunction, treatment with intense pulsed light (IPL) followed by meibomian gland expression (MGX) significantly reduced the number and severity of dry eye disease symptoms and signs over 15 weeks.

Key improvements included a 93% increase in tear breakup time and significant reductions in patient-reported symptoms and clinical signs, demonstrating the efficacy of this combined treatment approach for alleviating dry eye disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of intense pulsed light and meibomian gland expression efficacy on relieving signs and symptoms of dry eye disease due to meibomian gland dysfunction. Dell, SJ., Gaster, RN., Barbarino, SC., et al.[2022]

In a study of 120 subjects with dry eye disease due to meibomian gland dysfunction, treatment with intense pulsed light (IPL) combined with Meibomian gland expression (MGX) resulted in significantly greater improvements in tear break up time and symptom scores compared to warm compresses combined with MGX.

The IPL treatment led to a 2.3-second increase in tear break up time and a 38% reduction in symptom scores, indicating its effectiveness in alleviating dry eye symptoms, while the control group showed much smaller improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Intense Pulsed Light Combined With Meibomian Gland Expression for the Treatment of Dry Eye Disease Due to Meibomian Gland Dysfunction: A Multicenter, Randomized Controlled Trial. Yan, X., Hong, J., Jin, X., et al.[2023]

In a study of 35 patients with refractory dry eye, treatment with a combination of intense pulsed light (IPL) and meibomian gland expression (MGX) significantly improved dry eye symptoms, with 89% of patients reporting symptom relief.

The therapy also enhanced meibomian gland function in 77% of patients in at least one eye, indicating its effectiveness in addressing both symptoms and underlying gland issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapy of Intense Pulsed Light Therapy and Meibomian Gland Expression (IPL/MGX) Can Improve Dry Eye Symptoms and Meibomian Gland Function in Patients With Refractory Dry Eye: A Retrospective Analysis. Vegunta, S., Patel, D., Shen, JF.[2016]

In a study of 3,689 patients with meibomian gland dysfunction, both intense pulsed light (IPL) combined with meibomian gland expression (MGX) and MGX alone were found to be safe treatments, with low rates of adverse events (AEs) at 3.24% and 1.92%, respectively.

The IPL-MGX group experienced a higher incidence of significant AEs compared to the MGX group, leading to recommendations against IPL treatment for young children and certain patients with specific eye conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events of Intense Pulsed Light Combined With Meibomian Gland Expression Versus Meibomian Gland Expression in the Treatment of Meibomian Gland Dysfunction. Qiao, C., Li, L., Wang, H., et al.[2021]

Intense pulsed light (IPL) treatment applied directly to the eyelids significantly improved meibomian gland function and tear film stability in patients with meibomian gland dysfunction (MGD), as shown by better scores in meibomian gland yielding secretion and tear break-up time after treatment.

The study, involving 44 patients, demonstrated that IPL combined with meibomian gland expression (MGX) is a safe and effective approach for treating MGD, with only mild side effects reported, such as temporary pain and partial eyelash loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. Rong, B., Tang, Y., Tu, P., et al.[2022]

Intense pulsed light therapy (IPL) combined with meibomian gland expression (MGX) significantly improved various measures of dry eye disease in 160 patients, including visual acuity and tear quality, after four treatment sessions.

The treatment was found to be safe, with no adverse events reported, and patients with more severe dry eye symptoms experienced greater improvements, indicating its efficacy in managing meibomian gland dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of intense pulsed light of upper and lower eyelids in Meibomian gland dysfunction: A prospective multicentric study. Benitez-Del-Castillo, JM., López-Pérez, MD., Cano-Ortiz, A., et al.[2023]

In a study of 90 patients with meibomian gland dysfunction (MGD), combination therapy using intense pulsed light (IPL) and meibomian gland expression (MGX) showed significant improvement in symptoms after three or more treatment sessions, as measured by the ocular surface disease index (OSDI) scores.

The therapy also led to improvements in meibum quality and tear break-up time (BUT) after just one session, indicating that while some benefits can be seen early, more sessions are necessary for substantial symptomatic relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different Number of Sessions of Intense Pulsed Light and Meibomian Gland Expression Combination Therapy for Meibomian Gland Dysfunction. Lee, SH., Kim, M., Lee, WJ., et al.[2022]

Intense Pulsed Light (IPL) treatment significantly improved symptoms of severe Meibomian gland dysfunction (MGD)-related dry eye in 20 patients, with a notable decrease in symptom severity measured by Visual Analog Scale (VAS) and the SPEED score after three treatment sessions.

The treatment also increased the number of expressible Meibomian gland ducts, indicating improved gland function, while maintaining a good safety profile with only 15% of patients experiencing mild, transient ocular burning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of intense pulsed light therapy in the treatment of Meibomian gland dysfunction-related severe dry eye]. Egri, S., Van Hollebecke, I., Guindolet, D., et al.[2021]

Intense pulsed light therapy (IPL) combined with meibomian gland expression (MGX) significantly improves tear break-up time (TBUT) in patients with meibomian gland dysfunction (MGD) across various follow-up periods, indicating enhanced eye lubrication.

While there were nonsignificant improvements in dry eye symptoms measured by SPEED scores and Schirmer's test values, the overall results suggest that IPL with MGX is a promising treatment option for MGD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intense pulsed light therapy with meibomian gland expression for dry eye disease. Sambhi, RS., Sambhi, GDS., Mather, R., et al.[2021]

Citations

1. ctv.veeva.com ctv.veeva.com/study/clinical-study-evaluating-nordlys-swt-ipl-for-dry-eye-disease-ded-due-to-mgd

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye ... Subjects in the experimental group will receive four (4) IPL treatments and meibomian gland expression (MGX) at 2-week intervals. IPL pulses ...

2. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06064071

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye ... Subjects in the experimental group will receive four (4) IPL treatments and meibomian gland expression (MGX) at 2-week intervals. IPL pulses ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03396913

Effectiveness of Intense Pulsed Light for Improving Dry Eye ... The aim of the current study is to examine the contribution of intense pulsed light (IPL) for relieving signs and symptoms of dry eye due to meibomian gland ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39611367/

Effectiveness and safety of intense pulsed light therapy for ... This systematic review evaluates the effectiveness and safety of intense pulsed light (IPL) therapy for dry eye symptoms due to meibomian gland dysfunction ( ...

5. withpower.com withpower.com/trial/phase-dry-eye-syndromes-8-2023-45572

Light Therapy + MGX for Dry Eye Disease Trial Overview The clinical trial is testing Nordlys SWT IPL technology against a sham (fake) treatment for improving dry eye symptoms caused by meibomian gland ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06064071/clinical-study-evaluating-nordlystm-swt-ipl-for-dry-eye-disease-ded-due-to-mgd

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye ... Has at least 5 non-atrophied meibomian glands and at least 50% of working meibomianglands in the lower eyelid at screening/ baseline. Symptoms ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12440531/

Clinical study on the safety and efficacy of intense pulsed ... These results suggest that patients with diabetes experience more severe dry eye symptoms compared to nondiabetic individuals, with greater ...

8. 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 After four IPL/MGX treatments, a paired sample t-test showed a significant (p < 0.0001) decrease in SPEED2: 8 patients (23%) had a ≥ 50% ...