Evaluating a new light therapy for dry eye disease caused by meibomian gland dysfunction

Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD

This study is testing a new light therapy to see if it can help people with dry eye caused by meibomian gland problems feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Candela Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 3 sites (Miami, Florida and 2 other locations)
• Trial ID: NCT06064071 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of the Nordlys™ System with Selective Waveband Technology (SWT)® Intense Pulsed Light (IPL) for treating dry eye disease (DED) due to meibomian gland dysfunction (MGD). Participants will be randomly assigned to either an experimental group receiving active IPL treatments or a control group receiving sham treatments. The study involves four IPL sessions followed by meibomian gland expression at two-week intervals, with follow-up assessments at one and three months post-treatment. The goal is to compare the outcomes between the two groups to determine the efficacy of the treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 75 with specific criteria indicating dry eye disease due to meibomian gland dysfunction.

Not a fit: Patients who wear contact lenses or have certain ocular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients suffering from dry eye disease.

How similar studies have performed: Previous studies have shown promise with similar light therapy approaches for treating dry eye conditions, suggesting potential for success in this study.

Eligibility criteria

Inclusion Criteria:

* Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick Skin Type I - VI.
* Able and willing to comply with the treatment/follow-up schedule and requirements comply with all study (protocol) requirements.
* Willingness to provide signed, informed consent to participate in the study
* Willing to have photographs and images taken of the treated areas to be used in evaluations, publications, presentations, and marketing materials
* Has Tear Breakup Time (TBUT) ≤ 7 seconds at screening/baseline
* Has Meibomian gland secretion score (MGS) ≤ 12 at screening/ baseline
* Has at least 5 non-atrophied meibomian glands and at least 50% of working meibomian glands in the lower eyelid at screening/ baseline
* Symptoms self-assessed using the OSDI questionnaire ≥ 23 at screening/ baseline

Exclusion Criteria:

* Contact lens wear within the month prior to screening
* Unwilling to discontinue use of contact lenses for the duration of the study
* Ocular surgery or eyelid surgery, within 6 months prior to screening
* Neuro-paralysis in the planned treatment area, within 6 months prior to screening
* Other uncontrolled eye disorders affecting the ocular surface, for example active allergies
* Current use of punctal plugs
* Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatment area
* Uncontrolled infections or uncontrolled immunosuppressive diseases
* Subjects with ocular infections, within 6 months prior to screening
* Prior history of cold sores or rashes in the perioral area or in the planned treatment area that could be stimulated by light at a wavelength of 560 nm to 1200 nm, including: Herpes simplex 1 \& 2, Systemic Lupus erythematosus, and porphyria unless treated following a prophylactic regimen per principal investigator discretion.
* Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
* Over exposure to sun, within 4 weeks prior to screening
* Use of prescription eye drops for dry eye, within 7 days prior to screening, excluding artificial tears and glaucoma drops
* Radiation therapy to the head or neck, within 12 months prior to screening
* Planned radiation therapy, within 8 weeks after the last treatment session
* Treatment with chemotherapeutic agent, within 8 weeks prior to screening
* Planned chemotherapy, within 8 weeks after the last treatment session
* New topical treatments within the area to be treated, or oral therapies, within 3 months prior to screening- except over-the-counter acetaminophen-based analgesics for pain management, new oral omega 3 fatty acid supplements and topical artificial tears
* Change in dosage of any systemic medication, within 3 months prior to screening
* Anticipated relocation or extensive travel outside of the local study area preventing compliance with follow-up over the study period
* Legally blind in either eye
* History of migraines, seizures or epilepsy
* Facial IPL treatment within 12 months prior to screening
* Any thermal treatment of the eyelids, including Lipiflow, within 6 months prior to screening
* Expression of the meibomian glands, within 6 months prior to screening
* In either eye, moderate to severe inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis or severe inflammation of the eyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis
* Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
* Eyelid abnormalities that affect lid function in either eye, including: entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, and severe ptosis
* Any systemic condition that may cause dry eye disease, including: Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, and Sjögren's syndrome
* Unwilling or unable to abstain from the use of medications known to cause dryness (e.g., isotretinoin, antihistamines) throughout the study duration. Subjects must discontinue these medications for at least 1 month prior to the baseline visit.
* Any condition revealed whereby the investigator deems the subject inappropriate for this study

Where this trial is running

Miami, Florida and 2 other locations

• Center for Excellence in Eye Care — Miami, Florida, United States (Recruiting)
• Candela Institute of Excellence — Marlborough, Massachusetts, United States (Recruiting)
• Av. Del Libertador 662, Piso 17, Dept. 42 — Buenos Aires, Argentina (Not_yet_recruiting)

Study contacts

• Study coordinator: Maya Duffy

Conditions Meibomian Gland Dysfunction; Dry Eye Disease