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

Launched by CANDELA CORPORATION · Sep 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called the Nordlys™ System, which uses special light technology to help people with Dry Eye Disease (DED) caused by Meibomian Gland Dysfunction (MGD). The goal is to see if this treatment can improve the symptoms of dry eyes in participants. The study is currently recruiting individuals aged 18 to 75 who are generally healthy and have certain measurements related to their dry eye condition. For example, they must have a specific tear breakup time and a score indicating their dry eye symptoms.

Participants in the trial will receive the Nordlys™ treatment and will be asked to attend follow-up appointments to monitor their progress. They should be willing to have photos taken of their treatment areas for research purposes. It’s important for potential participants to know that they will need to avoid certain medications and treatments for their eyes before and during the study. If you meet the eligibility requirements and are interested in participating, this trial could be an opportunity to explore a new treatment for your dry eyes.

Gender

ALL

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