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

Inclusion Criteria:

• Healthy female and male subjects between 18 to 75 years of age with Fitzpatrick SkinType I - VI.

• Able and willing to comply with the treatment/follow-up schedule and requirementscomply 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 inevaluations, 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 meibomianglands 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 activeallergies

• Current use of punctal plugs

• Pre-cancerous lesions, skin cancer or pigmented lesions in the planned treatmentarea

• 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 plannedtreatment area that could be stimulated by light at a wavelength of 560 nm to 1200nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyriaunless treated following a prophylactic regimen per principal investigatordiscretion.

• Within 3 months prior to screening, use of photosensitive medication and/or herbsthat 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 3months prior to screening- except over-the-counter acetaminophen-based analgesicsfor pain management, new oral omega 3 fatty acid supplements and topical artificialtears

• Change in dosage of any systemic medication, within 3 months prior to screening

• Anticipated relocation or extensive travel outside of the local study areapreventing 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 toscreening

• 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 theeyelid, including: blepharochalasis, staphylococcal blepharitis or seborrheicblepharitis

• 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 severeptosis

• Any systemic condition that may cause dry eye disease, including: Stevens-Johnsonsyndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis,sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, andSjögren'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 mustdiscontinue these medications for at least 1 month prior to the baseline visit.

• Any condition revealed whereby the investigator deems the subject inappropriate forthis study