Feasibility of IPL Combined With RF for Treatment of DED Due to MGD

Recruiting at 1 trial location

Overseen By Haya Hamza, B.Sc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lumenis Ltd.

Must not be taking: Photosensitive medications

Disqualifiers: Sjogren, LASIK, Skin cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

33 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires a 4-week period without using any prescription eye drops, except for artificial lubricants. Non-prescription products for dry eye should not be used within 1 month of the study, except for artificial lubricants.

What is the purpose of this trial?

This trial is testing a new treatment for people with dry eyes caused by gland issues. The treatment uses special light pulses and radio waves to reduce swelling and warm the eyelids, providing both quick relief and long-term improvement.

Research Team

James Chelnis, MD

Principal Investigator

Manhattan Face and Eye

Chantel Garcia, OD

Principal Investigator

Carolina Eye Doctors

Eligibility Criteria

Inclusion Criteria

22 or older

You have moderate to severe dry eye.

Subject is able to read, understand and sign an IC form

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 treatments at 2-week intervals, consisting of IPL, RF, and MGX

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• IPL_RF_MGX

Participant Groups

Group I: Study arm Experimental Treatment 1 Intervention

Subjects will receive 4 treatments at 2-weeks intervals. Each treatment will consist of IPL administered on the malar region, followed by RF administered around the eye, followed by Meibomian gland expression (MGX). Follow-up will be conducted at 4 weeks after the 4th treatment session.

Who Is Running the Clinical Trial?

Lumenis Ltd.

Lead Sponsor

Trials

24

Recruited

670+

Lumenis Be Ltd.

Lead Sponsor

Trials

39

Recruited

1,500+