Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

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

Study Overview

• Status: Completed
• Conditions: Improvement of Dry Eye Disease
• Intervention / Treatment: Device: Forma Eye Applicator

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80016
      • Centennial Eye Associates
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Excellent Vision
  • Texas
    • Austin, Texas, United States, 78745
      • Sean Paul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Forma Eye treatment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in Standardized patient Evaluation of Eye Dryness (SPEED)	Mean change from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in Standardized Patient Evaluation of Eye Dryness (SPEED)	1month, 3 months, 6 months
Change in Meibomian Gland Score (MGS), as assessed by a masked rater	Changes from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in in Meibomian Gland Score (MGS), as assessed by a masked rater, and Tear Break-Up Time (TBUT).	1 month, 3 months, 6 months
Change in Tear Break-Up Time	Changes from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) assessed by Tear Break-up time (TBUT)	1 month, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's assessment of improvement	Subject assessment of improvement based on 0 - 4-point Likert scale at four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) follow up visits. Improvement assessment will be performed independently by the subject himself on the following 0-4 points Likert scale questionnaire (Global Aesthetic Improvement Scale): 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference	1 month, 3 months, 6 months
Subject assessment of satisfaction	Subject assessment of satisfaction will be filled-out by subjects only using 5-points Likert scale at four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) follow up visits: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed	1 month, 3 months, 6 months
Safety assessment	The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)	1 month, 3 months, 6 months
Safety assessment	Discomfort assessment during the treatment using NSR scale. At each treatment the subject will be asked to fill assessments for the pain/discomfort during the procedure. The subject will be asked to rate the severity from 0 to 10, with 0 equaling no symptoms and 10 equaling the worst possible symptoms. A number is obtained by measuring up to the point the subject has indicated	2 weeks, 4 weeks and 6 weeks
Mean change in Ocular Surface Disease Index (OSDI)	Mean change from baseline to prior to second, third treatments as well as four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) in Ocular Surface Disease Index (OSDI)	1 Month, 3 months, 6 months
Improvement in NEI grading measurements	Improvement measurements using ocular surface fluorescent staining. NEI grading scheme grading for ocular surface staining score will be used in this study.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: DO609175A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No