NCT06064071

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Candela Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Meibomian Gland Dysfunction
• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Nordlys SWT IPL	Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators
PROCEDURE	Meibomian Gland Expression (MGX)	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
DEVICE	Sham Nordlys SWT IPL	Sham treatment with Nordlys™ System with Selective Waveband Technology (SWT)® IPL Applicators device turned off

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2023-10-03
• Last updated: 2025-08-22

Locations

3 sites across 2 countries: United States, Argentina

Regulatory

• FDA-regulated device study