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

NCT06064071 | Active Not Recruiting FDA Device

• 1 other identifier: DED23001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 3

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).

Conditions

Meibomian Gland Dysfunction; Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up

  The difference in the change of TBUT from Baseline to Follow-Up, between eyes in the study group and eyes in the control group. TBUT is measured in seconds. Improvement is defined as a positive change of TBUT from Baseline to Follow Up. Measurement of TBUT will be implemented using fluorescein ophthalmic strips. Three successive readings will be taken and averaged to a single value.

  Baseline, 4-Week Follow Up (Week 10)

Secondary Outcomes (2)

• Difference in change of self-assessed symptoms with the Ocular Surface Disease Index (OSDI) questionnaire, from baseline to follow-up.

  Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18

• The difference in change of self-assessed symptoms of eye dryness via Eye Dryness Score (EDS) via visual analog scale (VAS), from baseline to follow-up

  Baseline, 1 Month Follow Up at Week 10, and 3 Month Follow Up at Week 18

Study Arms (2)

Experimental: Nordlys SWT IPL

EXPERIMENTAL

Subjects will receive up to four study Nordlys SWT IPL treatments and MGX

Device: Nordlys SWT IPL; Procedure: Meibomian Gland Expression (MGX)

Control Group: Sham Treatment

SHAM COMPARATOR

Subjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX

Procedure: Meibomian Gland Expression (MGX); Device: Sham Nordlys SWT IPL

Interventions

Nordlys SWT IPL DEVICE

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

Experimental: Nordlys SWT IPL

Meibomian Gland Expression (MGX) PROCEDURE

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

Control Group: Sham Treatment; Experimental: Nordlys SWT IPL

Sham Nordlys SWT IPL DEVICE

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

Control Group: Sham Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Candela Corporation: lead

Study Sites (3)

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

Candela Institute of Excellence

Marlborough, Massachusetts, 01752, United States

Location

Av. Del Libertador 662, Piso 17, Dept. 42

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: September 18, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AR (1)