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

NCT ID: NCT04120584

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2022-07-25

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Forma Eye treatment

Group Type: EXPERIMENTAL

Forma Eye Applicator

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult females and males between the ages of 18 -75, seeking treatments for Dry Eye Disease Due to Meibomian Gland Dysfunction

2. Tear breakup time (TBUT) ≤10 s;

3. Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure

4. Subjective symptom score (using the Standard Patient Evaluation of Eye Dryness [SPEED] questionnaire) ≥10;

5. At least one meibomian gland opening with a visible plugging over the eyelid margin

6. No ocular pathology requiring treatment other than eye lubricant and conventional eyelid hygiene within the last month and during the study

7. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits, and side effects, and sign the Informed Consent Form

8. The subjects should be willing to comply with the study procedure and schedule, including follow up visits.

9. Agreement/ability to abstain from dry eye/MGD medications or any device treatments for the time between the treatment visit and the final study visit. Ocular lubricants are allowed if no changes are made during the study.

Exclusion Criteria

1. Evidence of co-existing ocular conditions potentially posing an increased risk of procedure-related injury, (e.g., active ocular infection or inflammation in either eye)

2. History of ocular trauma or surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year

3. Ocular surface abnormality potentially compromising corneal integrity in either eye; eyelid abnormalities affecting lid function in either eye

4. Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjogren's syndrome)

5. Unwillingness to abstain from systemic medications known to cause dryness for the study duration.

6. Individuals who have either changed the dosing of systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to screening

7. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body

8. Permanent metal implant in the treatment area

9. Any surgery in the treatment area in the last 3 months

10. Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles

11. Pregnancy and nursing or females of childbearing potential and not utilizing adequate birth control measures

12. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications

13. Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.

14. Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary, and hormonal virilization

15. Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes, and rash.

16. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin

17. Severe concurrent conditions, such as cardiac disorders, sensory disturbances.

18. Use of Isotretinoin (Accutane®) within 6 months prior to treatment.

19. Participation in another study within 30 days prior to screening.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Paul, MD

Role: PRINCIPAL_INVESTIGATOR

4316 James Casey St Building F Suite 201, Austin, TX 78745, United States

Sandy Zhang-Nunes, MD

Role: PRINCIPAL_INVESTIGATOR

Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine

Locations

Centennial Eye Associates

Aurora, Colorado, United States

Excellent Vision

Portsmouth, New Hampshire, United States

Sean Paul

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

DO609175A

Identifier Type: -

Identifier Source: org_study_id