Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
Phase: NA
Conditions: Improvement of Dry Eye Disease
Sponsor: InMode MD Ltd.

Study title:    Clinical Evaluation of Safety and Efficacy of Radio 
Frequency (Forma Eye) Treatment for Dry Eye Disease Due to 
Meibomian Gland Dysfunction 
 
 
Date: May 2022 
 
Identifiers: NCT04120584 
 
Unique Protocol ID:  DO609175A 
 
 
 
Study Title 
Clinical Evaluation of Safety and Efficacy of Radio Frequency 
(Forma Eye) Treatment for Dry Eye Disease Due to Meibomian 
Gland Dysfunction 
Protocol Number 
DO609175A 
Sponsor 
InMode Ltd. 
Study Design 
Prospective, open label, clinical study. 
Planned Study Duration  Study duration including recruitment will be up to 12 months.  
Investigational Device  
Forma Eye handpiece 
Planned Sample Size 
At least 40 adult subjects with symptoms of evaporative dry 
eye/MGD 
Subject Selection 
 
Investigator will determine patient’s eligibility to participate in 
the study according to inclusion/exclusion criteria.  

Treatment and Duration 
Eligible subjects will receive up to 3 treatments (2-3 weeks 
interval) with the Forma Eye Applicator according to the study 
protocol. 
Site#1: 
First 5 subjects will receive up to 3 treatments (2-3 weeks 
interval) 
Another 15 subjects will receive 1 treatment 
Site#2: 
15 subjects will receive 1 treatment 
Site#3: 
5subjects will receive 1 treatment 
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. 
Study Objectives 
The objective of this trial is to evaluate the safety and efficacy 
of the Forma Eye Applicator for Symptoms of Dry Eye Disease 
Due to Meibomian Gland Dysfunction 
Secondary Objective 
The secondary objective of this study is subject satisfaction, as 
measured with a self-assessment questionnaire and a rating of 
device and procedure related adverse events. 
Main Endpoints 
Primary objectives will be measured using the next efficacy 
endpoints: 
• 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) 
• 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) 
• Improvement measurements using ocular surface 
fluorescent staining. NEI grading scheme grading for 
ocular surface staining score will be used in this study.   
• 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 
• 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 Tear Break-Up 
Time (TBUT).  
Secondary Endpoints  
• 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 
• 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 
• Safety assessment: 

o The number, severity and type of any adverse event 
recorded throughout the study and post treatment 
(immediate and delayed response)  
o Discomfort assessment during the treatment using 
NSR scale 
Statistical Methods 
Descriptive statistics will be used to present changes in the 
assessments along the study course.  
 
 
DATA ANALYSIS 
Statistical analysis of all major factors will be performed to determine 
quantitatively the treatment efficacy. 
The data will be analysed by the Sponsor using basic descriptive 
statistics, as well as comparison tests, where applicable. Treatment-
related complications will be monitored and reported; if applicable, 
their incidence rate will be calculated and analysed for any relationship 
to treatment parameters.