Light Therapy + MGX for Dry Eye Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Candela Corporation

Must not be taking: Photosensitizing drugs

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

Clinical Study Evaluating Nordlys™ System with Selective Waveband Technology (SWT)® Intense Pulsed Light (IPL) Applicators for Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD).

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 data supports the effectiveness of the treatment Light Therapy + MGX for Dry Eye Disease?

Research shows that using intense pulsed light (IPL) therapy along with meibomian gland expression (MGX) can help improve symptoms of dry eye disease by enhancing the function of the meibomian glands, which are crucial for eye lubrication. ^{1 2 3 4 5}

Is the combination of light therapy and meibomian gland expression safe for humans?

Research indicates that using intense pulsed light (IPL) combined with meibomian gland expression (MGX) is generally safe for treating meibomian gland dysfunction, which is related to dry eye disease. However, as with any treatment, there may be some adverse events (unwanted effects), so it's important to discuss potential risks with a healthcare provider. ^{1 2 6 7 8}

How is the Light Therapy + MGX treatment for dry eye disease different from other treatments?

This treatment combines intense pulsed light (IPL) therapy with meibomian gland expression (MGX) to target dry eye disease caused by meibomian gland dysfunction. Unlike standard treatments, IPL uses light to reduce inflammation and improve gland function, while MGX helps clear blockages, offering a unique dual approach to managing symptoms. ^{1 2 5 8 9}

Research Team

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Meibomian Gland Expression (MGX) (Procedure)
• Nordlys SWT IPL (Procedure)

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Center for Excellence in Eye Care Miami, FL

Candela Institute of Excellence Marlborough, MA

Who Is Running the Clinical Trial?

Candela Corporation

Lead Sponsor

Trials

22

Patients Recruited

2,200+

References

1. United States 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. [2023] To demonstrate that intense pulsed light therapy (IPL) of the upper and lower eyelids with meibomian gland expression (MGX) is effective in improving dry eye disease due to meibomian gland dysfunction (MGD).

2. New Zealand 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. [2022] The aim of this study was to estimate the efficacy of intense pulsed light (IPL), followed by meibomian gland expression (MGX), for reducing the number and severity of signs and symptoms of dry eye disease (DED) secondary to meibomian gland dysfunction (MGD).

3. United States 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. [2016] To assess the improvement in meibomian gland function and dry eye symptoms in patients with refractory dry eye treated with a combination therapy of intense pulsed light (IPL) and meibomian gland expression (MGX).

4. England pubmed.ncbi.nlm.nih.gov

Intense pulsed light therapy with meibomian gland expression for dry eye disease. [2021] To examine the effectiveness of intense pulsed light therapy (IPL) with meibomian gland expression (MGX) in treating meibomian gland dysfunction (MGD) and dry eye symptoms.

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Different Number of Sessions of Intense Pulsed Light and Meibomian Gland Expression Combination Therapy for Meibomian Gland Dysfunction. [2022] To evaluate the effect of the intense pulsed light (IPL) and meibomian gland (MG) expression (MGX) combination therapy according to the total numbers of sessions in the meibomian gland dysfunction (MGD).

6. United States 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. [2021] To analyze the occurrence and causes of adverse events (AEs) in intense pulsed light (IPL) combined with meibomian gland expression (MGX) and MGX treatment alone for meibomian gland dysfunction (MGD).

7. United States pubmed.ncbi.nlm.nih.gov

Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. [2022] To determine the efficacy and safety of intense pulsed light (IPL) applied directly on the eyelids and meibomian gland expression (MGX) in treating meibomian gland dysfunction (MGD).

8. United States 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. [2023] To compare the efficacy of intense pulsed light (IPL) combined with Meibomian gland expression (MGX), and instant warm compresses combined with MGX, for treatment of dry eye disease (DED) due to meibomian gland dysfunction (MGD).

9. France pubmed.ncbi.nlm.nih.gov

[Efficacy of intense pulsed light therapy in the treatment of Meibomian gland dysfunction-related severe dry eye]. [2021] Dry eye syndrome caused by Meibomian gland dysfunction (MGD) is a common disease in the general population and impairs quality of life. Intense Pulsed Light (IPL) has mainly been used in dermatology for the treatment of skin disorders, and more recently for MGD-related dry eye. The objective of our study is to evaluate the efficacy and tolerability of IPL with the E-Eye® device (E-Swin, Houdan, France) in severe MGD-related dry eye patients.