Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
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 TBUT ≤ 7 seconds at screening/baseline Has 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
Sites / Locations
- Center for Excellence in Eye CareRecruiting
- Candela Institute of ExcellenceRecruiting
- Av. Del Libertador 662, Piso 17, Dept. 42
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Experimental: Nordlys SWT IPL
Control Group: Sham Treatment
Subjects will receive up to four study Nordlys SWT IPL treatments and MGX
Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX