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Could a radio frequency device ease dry eye?

NCT ID NCT04120584

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a radio frequency device (Forma Eye) for dry eye caused by meibomian gland dysfunction. 47 adults received up to 3 treatments and were followed for 24 weeks. Researchers measured symptom scores, tear break-up time, and gland function to see if the treatment is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radio frequency device (Forma Eye Applicator)
What this could lead to
If it works, this could offer a non-drug option to ease dry eye symptoms and improve gland function.
What could go wrong
This is a small, completed early-stage study with no control group, so results may not be definitive or apply to everyone. Risks include temporary discomfort or no improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

47 people

The number who actually took part.

Started

Oct 2019

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. \-

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Centennial Eye Associates

    Aurora, Colorado, 80016, United States

  • Excellent Vision

    Portsmouth, New Hampshire, 03801, United States

  • Sean Paul

    Austin, Texas, 78745, United States