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

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

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

Conditions
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Improvement of Dry Eye Disease

Intervention / Treatment
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* Device: Forma Eye Applicator


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Forma Eye treatment<br> | Device: Forma Eye Applicator<br>* 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.<br>|

What is the study measuring?
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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 |