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Warm eyelid treatment for dry eye gets a boost?

NCT ID NCT07365735

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the TearCare MGX system, a device that applies heat to the eyelids, for treating dry eye caused by meibomian gland dysfunction. 21 adults with dry eye symptoms received the treatment, comparing a standard version with one that includes an extended warming hold. The goal was to see if the warming hold improves gland secretions and eye comfort.

What this could mean

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

Active substance
localized heat therapy device
What this could lead to
If successful, this could improve the treatment of evaporative dry eye by enhancing meibomian gland function.
What could go wrong
This is a small, early-stage trial with only 21 participants, so results may not apply to everyone. The device is already FDA-cleared, so the main question is whether the warming hold feature adds benefit.

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

21 people

The number who actually took part.

Started

Mar 2026

Finished

May 2026

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

22 years and older

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. Male or female subjects, 22 years of age or older 2. Reports dry eye symptoms within the past 6 months 3. OSDI score of 23 to 79 4. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye. 5. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. 6. Best corrected visual acuity of 20/100 or better, OU. 7. Willing and able to comply with the study procedures and follow-up 8. Understands and signs the informed consent. Exclusion Criteria: 1. Use of: 1. Cyclosporine, Xiidra, or serum tears within 60 days prior to Screening; 2. Antihistamines (oral or topical) within 7 days prior to Screening; 3. Oral tetracyclines or azithromycin within 30 days prior to Screening; 4. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to Screening 5. Isotretinoin (e.g. Accutane) at any time. 2. Any of the following dry eye treatments: 1. Office-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \[LipiFlow\], iLux etc.) within 12 months prior to Screening either as part of routine care or clinical investigation; 2. Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening); 3. Meibomian gland expression within 6 months prior to Screening; 4. Blephex or debridement within 3 months prior to Screening; 5. Punctal occlusion (including collagen, e.g. Soft Plug, UltraPlug, or crosslinked hyaluronic acid, e.g. Lacrifill) or punctal plugs within 15 days of the Screening visit; 6. Use of tear neurostimulators (i.e., True Tear, iTear100, Tyrvaya) within 2 weeks of the baseline visit. (Subjects must refrain from using tear neurostimulators for the duration of the study); 7. Any history of meibomian gland probing. 3. History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening. 4. Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery. 5. Contact lens use within 2 weeks of the Procedure visit. Subjects presenting at the Screening visit using contact lenses must agree to discontinue use for a full 2 weeks (14 days) prior to the Procedure visit. 6. Active hordeolum, stye, or chalazion at the time of the Screening visit. 7. History of Herpes Simplex or Herpes Zoster of the eye or eyelid. 8. Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation. 9. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to Screening. 10. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. 11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis). 12. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area. 13. In the clinical judgement of the Investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a cotton swab. 14. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea 15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis. 16. Ocular trauma within 3 months prior to Screening. 17. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation 18. Systemic diseases, in the Investigator's medical judgement, resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) 19. Subject is currently using Retin A /Retin A derivatives. 20. Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes. 21. Subject is currently using Latisse, Lash Boost or any other type of eyelash growth serum. Prostaglandin analog products such as Latisse should not be used within 30 days of the Screening visit. 22. Temporary false eyelashes, lash extensions, or any other type of false eyelash within 15 days of the Screening Visit. 23. Allergies to silicone tissue adhesives, acrylates and/or copper. 24. Subject has a pacemaker or implantable cardiac defibrillators (ICD). 25. Co-existing condition, either ocular or non-ocular that, in the judgement of the Investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Meibomian Gland Dysfunction

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cleveland Eye Clinic

    Brecksville, Ohio, 44141, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.