Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"

Inclusion criteria

• Patient is able to read, understand and sign an information consent and image right forms
• aged over 22 years old
• Fitzpatrick skin type I-IV
• Patient is able and willing to comply with the treatment/FU schedule and requirements
• Meibomian Gland Score : Meibum Quality according to Tear Film and Occular Surface Society recommendation: ≥ 16 for 1 eye and 8 central glands in the lower eyelid
• At least 5 non-atrophied meibomian glands in the lower eyelid
• Tear break-up time (TBUT) ≤ 10 seconds
• Symptoms self-assessed using the Occular Surface Disease Index questionnaire ≥ 23

Exclusion criteria

• Fitzpatrick skin type V or VI
• 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
• Patients 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 610 nm to 1200 nm, including: Herpes simplex 1 & 2, Systemic Lupus erythematosus, and porphyria
• Within 3 months prior to screening, use of photosensitive medication and/or herbs that may cause sensitivity to 610-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort
• Over exposure to sun, within 4 weeks prior to screening
• Using of topical drops, only artificial tears and glaucoma treatments are authorized
• 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 (face), or oral therapies, within 3 months prior to screening, analgesics for pain management, oral omega 3 fatty acid supplements are authorized
• 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 Itense Pulsed Light 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 (Grade 3-4 on the EFRON scale) inflammation of the conjunctiva, including: allergic, vernal or giant papillary conjunctivitis
• In either eye, severe (Grade 4 on the EFRON scale) 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 and pterigyum)
• 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. Patients must discontinue these medications for at least 1 month prior to the baseline visit.
• Any condition revealed whereby the investigator deems the Patient inappropriate for this study