Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD (NCT06064071) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
United States, Argentina100 participantsStarted 2023-09-18
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* P…
What they're measuring
1
Improvement of Tear Breakup Time (TBUT) from baseline to 4-week follow-up