Improvement of Dry Eye Disease
Conditions
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
Interventions
DEVICEForma 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.
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Patient Evaluation of Eye Dryness (SPEED) | 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. |
| Meibomian Gland Score (MGS), as Assessed by a Masked Rater | 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. |
| Tear Break-Up Time | 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. |
| Ocular Surface Disease Index (OSDI) | 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. |
| Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's Assessment of Improvement | 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). |
| Subject Assessment of Satisfaction | 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. |
| Safety Assessment | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Forma-Eye treatment 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Forma-Eye treatment | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 31 Participants | — |
| Age, Continuous | 47.79 years | — |
| Corneal Surface fluorescent staining using NEI (National Eye Institute) grading Left eye | 2.85 score on a scale STANDARD_DEVIATION 1.51 | — |
| Corneal Surface fluorescent staining using NEI (National Eye Institute) grading Right eye | 2.7 score on a scale STANDARD_DEVIATION 1.15 | — |
| Meibomian Gland Score (MGS), as Assessed by a Masked Rater Left Eye | 5.32 score on a scale STANDARD_DEVIATION 3.13 | — |
| Meibomian Gland Score (MGS), as Assessed by a Masked Rater Right Eye | 6 score on a scale STANDARD_DEVIATION 4.17 | — |
| Ocular Surface Disease Index (OSDI) | 34.5 score on scale STANDARD_DEVIATION 18.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
| Standardized Patient Evaluation of Eye Dryness (SPEED) | 15.647 score on scale STANDARD_DEVIATION 4.7 | — |
| Tear Break-Up Time Left eye | 2.9 score on a scale STANDARD_DEVIATION 2.06 | — |
| Tear Break-Up Time Right eye | 2.77 score on a scale STANDARD_DEVIATION 1.56 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 2 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Forma Eye treatment | Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading | Right eye | 0.18 score on a scale | Standard Deviation 0.77 |
| Forma Eye treatment | Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading | Left eye | 0.8 score on a scale | Standard Deviation 0.19 |
Primary
Meibomian Gland Score (MGS), as Assessed by a Masked Rater
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Forma Eye treatment | Meibomian Gland Score (MGS), as Assessed by a Masked Rater | Right eye | 21.8 score on a scale | Standard Deviation 11.26 |
| Forma Eye treatment | Meibomian Gland Score (MGS), as Assessed by a Masked Rater | Left Eye | 23.9 score on a scale | Standard Deviation 12.84 |
p-value: <0.001ANOVA
Primary
Ocular Surface Disease Index (OSDI)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forma Eye treatment | Ocular Surface Disease Index (OSDI) | 23.5 score on a scale | Standard Deviation 18.59 |
Primary
Standardized Patient Evaluation of Eye Dryness (SPEED)
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forma Eye treatment | Standardized Patient Evaluation of Eye Dryness (SPEED) | 9.6 score on a scale | Standard Deviation 5.79 |
p-value: <0.001ANOVA
Primary
Tear Break-Up Time
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.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Forma Eye treatment | Tear Break-Up Time | Right eye | 7.1 seconds | Standard Deviation 3.5 |
| Forma Eye treatment | Tear Break-Up Time | Left eye | 7.055 seconds | Standard Deviation 2.76 |
Secondary
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. Scale range: 0 (no pain) to 10 (worst possible pain).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forma Eye treatment | Safety Assessment | 1.6 units on a scale | Standard Deviation 1.9 |
Secondary
Subject Assessment of Satisfaction
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Forma Eye treatment | Subject Assessment of Satisfaction | 1 score on a scale | Standard Deviation 0.87 |
Secondary
Subject's Assessment of Improvement
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).
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Forma Eye treatment | Subject's Assessment of Improvement | 1.71 score on a scale | Standard Deviation 1.48 |