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

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

NCT06064071•Candela Corporation

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 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•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.
+21 more criteria

Locations (3)

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

Key Dates

Start Date

September 18, 2023

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

August 22, 2025

Enrollment

100

ESTIMATED participants

Conditions

Meibomian Gland DysfunctionDry Eye Disease

Interventions

Nordlys SWT IPL

DEVICE

Meibomian Gland Expression (MGX)

PROCEDURE

Sham Nordlys SWT IPL

DEVICE

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

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Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon