Clinical trial NCT04120584: Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Official title: Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement of Dry Eye Disease
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

    -

Primary outcomes:
measure: Mean change in Standardized patient Evaluation of Eye Dryness (SPEED)
timeFrame: 1month, 3 months, 6 months
measure: Change in Meibomian Gland Score (MGS), as assessed by a masked rater
timeFrame: 1 month, 3 months, 6 months
measure: Change in Tear Break-Up Time
timeFrame: 1 month, 3 months, 6 months
Secondary outcomes:
measure: Subject's assessment of improvement
timeFrame: 1 month, 3 months, 6 months
measure: Subject assessment of satisfaction
timeFrame: 1 month, 3 months, 6 months
measure: Safety assessment
timeFrame: 1 month, 3 months, 6 months
measure: Safety assessment
timeFrame: 2 weeks, 4 weeks and 6 weeks
measure: Mean change in Ocular Surface Disease Index (OSDI)
timeFrame: 1 Month, 3 months, 6 months
measure: Improvement in NEI grading measurements
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Centennial Eye Associates
state: Colorado
city: Portsmouth
country: United States
facility: Excellent Vision
state: New Hampshire
city: Austin
country: United States
facility: Sean Paul
state: Texas
Study officials:
affiliation: 4316 James Casey St Building F Suite 201, Austin, TX 78745, United States
name: Sean Paul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine
name: Sandy Zhang-Nunes, MD
role: PRINCIPAL_INVESTIGATOR
References: