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

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