Status:
ACTIVE_NOT_RECRUITING
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Lead Sponsor:
Candela Corporation
Conditions:
Meibomian Gland Dysfunction
Dry Eye Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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).
Detailed Description
Subjects will be randomized 1:1 to an experimental study group and a sham comparator (control) group. Subjects in the experimental group will receive four (4) IPL treatments and meibomian gland expre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06064071
Start Date
September 18 2023
End Date
September 1 2025
Last Update
August 22 2025
Active Locations (3)
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1
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
2
Candela Institute of Excellence
Marlborough, Massachusetts, United States, 01752
3
Av. Del Libertador 662, Piso 17, Dept. 42
Buenos Aires, Argentina