Improvement of Dry Eye DiseaseNCT04120584
Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
A study testing Forma Eye Applicator in people with Improvement of Dry Eye Disease, run by InMode MD Ltd. at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Improvement of Dry Eye Disease
- What is being tested?
- Forma Eye Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Oct 2019to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Centennial Eye Associates
Aurora, Colorado, 80016
Sean Paul
Austin, Texas, 78745
Excellent Vision
Portsmouth, New Hampshire, 03801
About this study
Official title: Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for dry eye disease due to meibomian gland dysfunction
- Conditions
- Improvement of Dry Eye Disease
- Being tested
- Forma Eye Applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forma Eye ApplicatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Forma Eye treatment | Experimental | Not described Receives: Device: Forma Eye Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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
- = Inspissated/toothpaste-like secretion
- = Cloudy secretion
- = 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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (3)
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).
Measured: 6 months
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.
Measured: 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.
Scale range: 0 (no pain) to 10 (worst possible pain).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start22 Oct 2019
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Improvement of Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- InMode MD Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Paul, MD, Principal investigator, 4316 James Casey St Building F Suite 201, Austin, TX 78745, United StatesSandy Zhang-Nunes, MD, Principal investigator, Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120584
- Sponsor's protocol ID
- DO609175A
- Status last verified
- Jun 2024
- First submitted
- 4 Oct 2019
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Safety and Efficacy of Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT04120584
- Acronym / sponsor ID
- DO609175A
- Conditions
- Improvement of Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- InMode MD Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Posted 24 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the safety and efficacy of radiofrequency treatment for dry eye disease due to meibomian gland dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Forma Eye treatment | Experimental | Device: Forma Eye Applicator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forma Eye ApplicatorEligible 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. | Device | Forma Eye treatment |
Primary outcome
Standardized Patient Evaluation of Eye Dryness (SPEED)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Subject's Assessment of Improvement
Time frame: 6 months
Subject Assessment of Satisfaction
Time frame: 6 months
Safety Assessment
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
Real-World Assessment of VEVYE® for Short-Term Symptom and Sign Improvement of Dry Eye Disease in a Neuro-Ophthalmology Clinic: A 6-Month Prospective Observational Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Paul, MD principal investigator
4316 James Casey St Building F Suite 201, Austin, TX 78745, United States
Sandy Zhang-Nunes, MD principal investigator
Oculofacial Plastic Surgery Director USC Roski Eye Institue USC Keck School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forma Eye Applicator in people with Improvement of Dry Eye Disease, run by InMode MD Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Patient Evaluation of Eye Dryness (SPEED) (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.