CompletedNot Applicable

Radio Frequency (Forma Eye) Treatment for Dry Eye Disease Due to Meibomian Gland Dysfunction

United States47 participantsStarted 2019-10-22

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Standardized Patient Evaluation of Eye Dryness (SPEED)

Timeframe: 6 months

Meibomian Gland Score (MGS), as Assessed by a Masked Rater

Timeframe: 6 months

Tear Break-Up Time

Timeframe: 6 months

Ocular Surface Disease Index (OSDI)

Timeframe: 6 months

Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading

Timeframe: 6 months

Trial details

NCT IDNCT04120584

SponsorInMode MD Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-25

Results submitted2022-11-30

View on ClinicalTrials.gov More Improvement of Dry Eye Disease trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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)

What they're measuring

Standardized Patient Evaluation of Eye Dryness (SPEED)

Timeframe: 6 months

Meibomian Gland Score (MGS), as Assessed by a Masked Rater

Timeframe: 6 months

Tear Break-Up Time

Timeframe: 6 months

Ocular Surface Disease Index (OSDI)

Timeframe: 6 months

Corneal Surface Fluorescent Staining Using NEI (National Eye Institute) Grading

Timeframe: 6 months