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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Meibomian Gland Dysfunction, Dry Eye Disease

In brief

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).

Key facts

Study ID

NCT06064071

Run by

Candela Corporation

People needed

100

Starts

2023-09-18

Expected to finish

2025-09-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Excellence in Eye Care — Miami, Florida, United States
• Candela Institute of Excellence — Marlborough, Massachusetts, United States
• Av. Del Libertador 662, Piso 17, Dept. 42 — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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