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Meibomian Gland DysfunctionNCT06064071

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

A study testing Nordlys SWT IPL and Meibomian Gland Expression (MGX) in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by Candela Corporation at 3 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Meibomian Gland Dysfunction, Dry Eye Disease
What is being tested?
Nordlys SWT IPL and Meibomian Gland Expression (MGX)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
3 sitesin 2 countries
Study dates
18 Sep 2023to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • Candela Institute of Excellence

    Marlborough, Massachusetts, 01752

  • Center for Excellence in Eye Care

    Miami, Florida, 33176

Other trials in United States

Argentina1 site

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

    Buenos Aires

Other trials in Argentina

About this study

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).

Read the 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 expression (MGX) at 2-week intervals. IPL pulses will be administered on the skin of the malar region and below the lower eyelids. Following IPL therapy, subjects will undergo MGX of both eyelids in both eyes. Subjects in the control group will receive the same treatment (IPL followed by MGX), except that the IPL administration will be performed with the device off (sham treatment). Follow-up visits will occur at 1 month and 3 months after the final treatment session. At the follow-up, the changes in the outcome measures will be evaluated and compared between the two groups.

Being tested
Nordlys SWT IPL, Meibomian Gland Expression (MGX), Sham Nordlys SWT IPL
Medical subject headings
Meibomian Gland Dysfunction, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nordlys SWT IPLDevice

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

  • Meibomian Gland Expression (MGX)Procedure or surgery

    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

  • Sham Nordlys SWT IPLDevice

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

Study groups in NCT06064071
Study groupRoleWhat they receive
Experimental: Nordlys SWT IPLExperimentalSubjects will receive up to four study Nordlys SWT IPL treatments and MGX
Receives: Device: Nordlys SWT IPL; Procedure: Meibomian Gland Expression (MGX)
Control Group: Sham TreatmentSham comparatorSubjects will receive up to four sham study Nordlys SWT IPL treatments (device turned off) and MGX
Receives: Procedure: Meibomian Gland Expression (MGX); Device: Sham Nordlys SWT IPL

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 4-Week Follow Up (Week 10)

Secondary outcomes (2)

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

    The difference in the change of OSDI from baseline to FU, between subjects in the study group and subjects in the control group. The minimal number is 0 and the maximal number is 100. Higher scores mean worse outcome. A score of 0-12 is considered normal. A score of 13-22 is consistent with mild dry eye. A score of 23 to 32 is consistent with moderate dry eye. A score from 33 to 100 is consistent with severe dry eye. The improvement of OSDI is defined as a negative change of OSDI from BL to FU.

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

  2. 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

    A qualitative test to visualize the production of sweat to the affected body area and assist in determining the area requiring treatment. Values will be collected separately for each eye. Correlation between eyes was removed by statistical methods. Scores were 0 (minimum) to 100 (maximum). Higher scores = worse outcome. The improvement of EDS is defined as a negative change of EDS from baseline to follow-up.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start18 Sep 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064071
Sponsor's protocol ID
DED23001
Status last verified
Oct 2026
First submitted
26 Sep 2023
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nordlys SWT IPL and Meibomian Gland Expression (MGX) in people with Meibomian Gland Dysfunction and Dry Eye Disease, run by Candela Corporation at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up (time frame: Baseline, 4-Week Follow Up (Week 10)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06064071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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