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 range18 Years – 75 Years

SexALL

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)
✕. 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
✕. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
✕. Permanent metal implant in the treatment area

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 range18 Years – 75 Years

SexALL

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)
✕. 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
✕. Internal defibrillator, a pacemaker or any other implanted electrical device anywhere in the body
✕. Permanent metal implant in the treatment area

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