Warm eyelid treatment for dry eye gets a boost?
NCT ID NCT07365735
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Evaporative dry eye disease due to meibomian gland dysfunction are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Cleveland Eye Clinic
Brecksville, Ohio, 44141, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can acne drug harm the eyes? new study investigates
- Artificial eye users may face hidden dry eye damage
- Warm eyelid therapy offers hope for young dry eye sufferers
- Could a daily supplement soothe dry eyes?
- Blink app may save your eyes from screen burn
- Light Therapy's secret: scientists probe tear changes for dry eye clues