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

NCT04120584 | Completed Results FDA Device

• 1 other identifier: DO609175A
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (5)

• Standardized Patient Evaluation of Eye Dryness (SPEED)

  Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.

  6 months

• Meibomian Gland Score (MGS), as Assessed by a Masked Rater

  The Meibomian Gland Score (MGS) is a standardized clinical tool used to assess the functional quality of the meibomian glands, which are responsible for secreting the oily layer of the tear film. Dysfunction in these glands is a common cause of dry eye disease and evaporative dry eye. The scoring typically involves gentle expression of the meibomian glands, usually from a designated number of glands (commonly 15, e.g., 5 each from the nasal, central, and temporal parts of the lower eyelid). Each gland is evaluated based on the quality of the secretion it produces. Scoring Criteria per Gland: Each gland is scored on a 0-3 scale: 0 = No secretion 1. = Inspissated/toothpaste-like secretion 2. = Cloudy secretion 3. = Clear, healthy oil If 15 glands are assessed, the maximum total score is 45 (15 glands × 3 points per gland). A higher total MGS reflects better meibomian gland function and healthier tear film, indicating a more favorable condition.

  6 months

• Tear Break-Up Time

  Tear Break-Up Time (TBUT) Changes in dry eye symptoms such as ocular fatigue or dryness will be assessed by TBUT. The measurement is reported in seconds. * Scale range: 0 seconds (minimum) to \>10 seconds (maximum normal value considered). * Interpretation: \>10 seconds = normal, 5-10 seconds = marginal, \<5 seconds = low.

  6 months

• Ocular Surface Disease Index (OSDI)

  Ocular Surface Disease Index (OSDI) This 12-item questionnaire assesses dry eye symptoms and their effects. Scale range: 0 (minimum) to 100 (maximum). Interpretation: Lower scores indicate better outcomes.

  6 months

• Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading

  Change in measurements using ocular surface fluorescent staining. The NEI scale divides the corneal and conjunctival surfaces to grade fluorescein uptake. Each of 5 areas per cornea is graded 0-3. The NEI scale for grading fluorescein staining divides the corneal and conjunctival surfaces to help measure fluorescein uptake. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Scale range: 0 (minimum; no staining) to 15 (maximum). Interpretation: Lower scores indicate better outcomes.

  6 months

Secondary Outcomes (3)

• Subject's Assessment of Improvement

  6 months

• Subject Assessment of Satisfaction

  6 months

• Safety Assessment

  6 weeks

Study Arms (1)

Forma Eye treatment

EXPERIMENTAL

Device: Forma Eye Applicator

Interventions

Forma Eye Applicator 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.

Forma Eye treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult females and males between the ages of 18 -75, seeking treatments for Dry Eye Disease Due to Meibomian Gland Dysfunction
• Tear breakup time (TBUT) ≤10 s;
• 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
• Subjective symptom score (using the Standard Patient Evaluation of Eye Dryness \[SPEED\] questionnaire) ≥10;
• At least one meibomian gland opening with a visible plugging over the eyelid margin
• No ocular pathology requiring treatment other than eye lubricant and conventional eyelid hygiene within the last month and during the study
• 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
• The subjects should be willing to comply with the study procedure and schedule, including follow up visits.
• 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.

You may not qualify if:

• 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)
• History of ocular trauma or surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year
• Ocular surface abnormality potentially compromising corneal integrity in either eye; eyelid abnormalities affecting lid function in either eye
• 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)
• Unwillingness to abstain from systemic medications known to cause dryness for the study duration.
• Individuals who have either changed the dosing of systemic or non-dry eye/MGD ophthalmic medication within the past 30 days prior to screening
• Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
• Permanent metal implant in the treatment area
• Any surgery in the treatment area in the last 3 months
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• Pregnancy and nursing or females of childbearing potential and not utilizing adequate birth control measures
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications
• 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.
• Poorly controlled endocrine disorders, such as diabetes, thyroid dysfunction, polycystic ovary, and hormonal virilization
• Any active condition in the treatment area, such as but not limited to open sores, psoriasis, eczema, vitiligo, herpes, and rash.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (3)

Centennial Eye Associates

Aurora, Colorado, 80016, United States

Location

Excellent Vision

Portsmouth, New Hampshire, 03801, United States

Location

Sean Paul

Austin, Texas, 78745, United States

Location

Results Point of Contact

• Title: Maria Shusterman
• Organization: Inmode

Maria.Shusterman@inmodemd.com

9057076787

Study Officials

• Sean Paul, MD

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

  PRINCIPAL INVESTIGATOR

• Sandy Zhang-Nunes, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 9, 2019
• Study Start: October 22, 2019
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2024-06

Locations

US (3)