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

InMode

Status

Completed

Conditions

Improvement of Dry Eye Disease

Treatments

Device: Forma Eye Applicator

Study type

Interventional

Funder types

Industry

Identifiers

NCT04120584

DO609175A

Details and patient eligibility

About

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

Enrollment

35 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
Severe concurrent conditions, such as cardiac disorders, sensory disturbances.
Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
Participation in another study within 30 days prior to screening.