Resumen

Estudio clínico de evaluación del sistema Nordlys™ con tecnología de banda selectiva (SWT)® y aplicadores de luz pulsada intensa (IPL) para la enfermedad del ojo seco (EOS) debida a disfunción de las glándulas de Meibomio (DGM).

Descripción detallada

Los sujetos serán aleatorizados 1:1 a un grupo experimental y a un grupo comparador simulado (control). Los sujetos del grupo experimental recibirán cuatro (4) tratamientos con IPL y expresión de las glándulas de Meibomio (MGX) a intervalos de 2 semanas. Los pulsos de IPL se administrarán sobre la piel de la región malar y por debajo de los párpados inferiores. Tras la terapia IPL, los sujetos serán sometidos a MGX de ambos párpados en ambos ojos. Los sujetos del grupo control recibirán el mismo tratamiento (IPL seguido de MGX), excepto que la administración de IPL se realizará con el dispositivo apagado (tratamiento simulado). Las visitas de seguimiento se realizarán 1 mes y 3 meses después de la sesión de tratamiento final. En el seguimiento se evaluarán y compararán entre los dos grupos los cambios en las medidas de resultado.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

device

Nordlys SWT IPL

Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators

procedure

Meibomian Gland Expression (MGX)

Meibomian glands are squeezed (by applying force on the inner and outer surfaces of the eyelid with a specially designed forceps, Q-tips, or fingers) in order to unclog obstructed glands and evacuate their content (the meibum), which in MGD is often viscous and thus causing obstruction

device

Sham Nordlys SWT IPL

Sham treatment with Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators device turned off

Estudio clínico de evaluación del sistema Nordlys™ SWT IPL para la enfermedad del ojo seco (EOS) debida a disfunción de las glándulas de Meibomio (DGM)