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Active Not Recruiting NCT06064071

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

Conditions: Meibomian Gland Dysfunction, Dry Eye Disease

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 100
Sponsor: Candela Corporation

Location: Center for Excellence in Eye Care Miami Florida

Summary

Clinical Study Evaluating Nordlys™ System with Selective Waveband Technology (SWT)® Intense Pulsed Light (IPL) Applicators for Dry Eye Disease (DED) due to Meibomian Gland Dysfunction (MGD).

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06064071). StuddyBuddy aggregates publicly available trial information.