Trial Outcomes & Findings for Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction (NCT NCT04120584)

Results Overview

Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

47 participants

Primary outcome timeframe

6 months

Results posted on

2025-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Forma Eye treatment Forma Eye Applicator: Eligible subjects will receive up to 3 treatments in both eyes (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.
Overall Study STARTED	47
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

47 included 35 complete the study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Forma-Eye treatment n=35 Participants Eligible subjects will receive up to 3 treatments in both eyes(2-3 weeks interval) with the Forma Eye Applicator according to the study protocol.
Age, Categorical <=18 years	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=35 Participants
Age, Categorical >=65 years	4 Participants n=35 Participants
Age, Continuous	47.79 years n=35 Participants
Sex: Female, Male Female	27 Participants n=35 Participants • 47 included 35 complete the study
Sex: Female, Male Male	8 Participants n=35 Participants • 47 included 35 complete the study
Standardized Patient Evaluation of Eye Dryness (SPEED)	15.647 score on scale STANDARD_DEVIATION 4.7 • n=35 Participants
Meibomian Gland Score (MGS), as Assessed by a Masked Rater Right Eye	6 score on a scale STANDARD_DEVIATION 4.17 • n=35 Participants
Meibomian Gland Score (MGS), as Assessed by a Masked Rater Left Eye	5.32 score on a scale STANDARD_DEVIATION 3.13 • n=35 Participants
Tear Break-Up Time Right eye	2.77 score on a scale STANDARD_DEVIATION 1.56 • n=35 Participants
Tear Break-Up Time Left eye	2.9 score on a scale STANDARD_DEVIATION 2.06 • n=35 Participants
Ocular Surface Disease Index (OSDI)	34.5 score on scale STANDARD_DEVIATION 18.6 • n=35 Participants
Corneal Surface fluorescent staining using NEI (National Eye Institute) grading Right eye	2.7 score on a scale STANDARD_DEVIATION 1.15 • n=35 Participants
Corneal Surface fluorescent staining using NEI (National Eye Institute) grading Left eye	2.85 score on a scale STANDARD_DEVIATION 1.51 • n=35 Participants

PRIMARY outcome

Timeframe: 6 months

Change dry eye symptoms evaluated by Standardized Patient Evaluation of Eye Dryness (SPEED) This questionnaire gives a score from 0 to 28. Lower score indicates better outcome. 0-4: mild, 5-7: moderate, 8+: severe Scale range: 0 (minimum; no symptoms) to 28 (maximum; most severe symptoms). Interpretation: Lower scores indicate better outcomes. Symptom severity can be categorized as: 0-4 = mild, 5-7 = moderate, 8-28 = severe.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Standardized Patient Evaluation of Eye Dryness (SPEED)	9.6 score on a scale Standard Deviation 5.79

PRIMARY outcome

Timeframe: 6 months

The Meibomian Gland Score (MGS) is a standardized clinical tool used to assess the functional quality of the meibomian glands, which are responsible for secreting the oily layer of the tear film. Dysfunction in these glands is a common cause of dry eye disease and evaporative dry eye. The scoring typically involves gentle expression of the meibomian glands, usually from a designated number of glands (commonly 15, e.g., 5 each from the nasal, central, and temporal parts of the lower eyelid). Each gland is evaluated based on the quality of the secretion it produces. Scoring Criteria per Gland: Each gland is scored on a 0-3 scale: 0 = No secretion 1. = Inspissated/toothpaste-like secretion 2. = Cloudy secretion 3. = Clear, healthy oil If 15 glands are assessed, the maximum total score is 45 (15 glands × 3 points per gland). A higher total MGS reflects better meibomian gland function and healthier tear film, indicating a more favorable condition.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Meibomian Gland Score (MGS), as Assessed by a Masked Rater Right eye	21.8 score on a scale Standard Deviation 11.26
Meibomian Gland Score (MGS), as Assessed by a Masked Rater Left Eye	23.9 score on a scale Standard Deviation 12.84

PRIMARY outcome

Timeframe: 6 months

Tear Break-Up Time (TBUT) Changes in dry eye symptoms such as ocular fatigue or dryness will be assessed by TBUT. The measurement is reported in seconds. * Scale range: 0 seconds (minimum) to \>10 seconds (maximum normal value considered). * Interpretation: \>10 seconds = normal, 5-10 seconds = marginal, \<5 seconds = low.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Tear Break-Up Time Right eye	7.1 seconds Standard Deviation 3.50
Tear Break-Up Time Left eye	7.055 seconds Standard Deviation 2.76

PRIMARY outcome

Timeframe: 6 months

Ocular Surface Disease Index (OSDI) This 12-item questionnaire assesses dry eye symptoms and their effects. Scale range: 0 (minimum) to 100 (maximum). Interpretation: Lower scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Ocular Surface Disease Index (OSDI)	23.5 score on a scale Standard Deviation 18.59

PRIMARY outcome

Timeframe: 6 months

Change in measurements using ocular surface fluorescent staining. The NEI scale divides the corneal and conjunctival surfaces to grade fluorescein uptake. Each of 5 areas per cornea is graded 0-3. The NEI scale for grading fluorescein staining divides the corneal and conjunctival surfaces to help measure fluorescein uptake. A standardized grading system of 0 to 3 is used for each of the five areas on each cornea. Scale range: 0 (minimum; no staining) to 15 (maximum). Interpretation: Lower scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading Right eye	0.18 score on a scale Standard Deviation 0.77
Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading Left eye	0.8 score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: 6 months

Subject assessment of improvement based on 0 - 4-point Likert scale. 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 Scale range: 0 (no difference) to 4 (significant marked improvement).

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Subject's Assessment of Improvement	1.71 score on a scale Standard Deviation 1.48

SECONDARY outcome

Timeframe: 6 months

Subject assessment of satisfaction will be filled-out by subjects only using 5-points Likert scale: +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. Scale range: -2 (very disappointed) to +2 (very satisfied). Interpretation: Higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Subject Assessment of Satisfaction	1 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: 6 weeks

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. Scale range: 0 (no pain) to 10 (worst possible pain).

Outcome measures

Outcome measures
Measure	Forma Eye treatment n=35 Participants 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.
Safety Assessment	1.6 units on a scale Standard Deviation 1.9

Adverse Events

Forma Eye treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Forma Eye treatment n=47 participants at risk 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.
Eye disorders conjuctivitis	2.1% 1/47 • Number of events 1 • 6 months
Eye disorders swollen lids	2.1% 1/47 • Number of events 1 • 6 months

Additional Information

Maria Shusterman

Inmode

Phone: 9057076787

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place