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Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

NCT04120584 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-10-24

Study results available
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Summary

The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for dry eye disease due to meibomian gland dysfunction

Conditions

  • Improvement of Dry Eye Disease

Interventions

DEVICE

Forma Eye Applicator

Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol. The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment.

Sponsors & Collaborators

  • InMode MD Ltd.

    lead INDUSTRY

Principal Investigators

  • Sean Paul, MD · 4316 James Casey St Building F Suite 201, Austin, TX 78745, United States

  • Sandy Zhang-Nunes, MD · Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-22
Primary Completion
2022-07-25
Completion
2022-07-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120584 on ClinicalTrials.gov