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Warm eyelid treatment shows promise for dry eye sufferers

NCT ID NCT03588624

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested the TearCare system, a device that gently heats the eyelids for 15 minutes followed by manual expression, in 29 adults with dry eye disease. The goal was to see if a single treatment could improve tear film stability and reduce dry eye symptoms over one month. The device aims to unblock oil glands in the eyelids to improve tear quality.

What this could mean

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

Active substance
TearCare device (thermal eyelid treatment)
What this could lead to
If it works, this could provide a non-drug option to relieve dry eye symptoms for up to a month.
What could go wrong
This was a small, short-term study with only 29 participants, so results may not apply to everyone. The device requires a procedure and may not work for all types of dry eye.

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

29 people

The number who actually took part.

Started

Jul 2018

Finished

Nov 2018

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

Accepted

You do not need to have the condition being studied to take part.

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. At least 22 years of age 2. Reports dry eye symptoms within the past 3 months 3. Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms. 4. OSDI Score of ≥23 5. TBUT of ≤7 seconds in both eyes 6. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤15 in each eye. 7. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. 8. Best spectacle corrected visual acuity of 20/100 or better in both eyes. 9. Willing and able to comply with the study procedures and follow-up 10. Willing and able to provide informed consent 11. English-speaking Exclusion Criteria: 1. Any active, clinically significant ocular or peri-ocular infection or inflammation 2. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment 3. History of eyelid, conjunctiva or corneal surgery (including refractive surgery) within the past year. In addition, subjects with any history of the following are excluded: chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery. 4. Any office-based dry eye treatment (e.g. IPL, thermal pulsation \[Lipiflow\], etc.) within 12 months prior to enrollment. In addition Blephex or debridement within 3 months prior to enrollment is an exclusion. 5. Meibomian gland expression within 6 months prior to enrollment. In addition, any history of meibomian gland probing is an exclusion. 6. In the clinical judgement of the investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a sterile cotton swab. 7. Contact lens use within the past 2 weeks (Subjects must refrain from wearing contact lenses for the duration of the study.) 8. Use of TrueTear device within the past 2 weeks (Subjects must refrain from using the TrueTear device for the duration of the study.) 9. History of Ocular Herpes Simplex or Ocular Herpes Zoster 10. Clinically significant ocular surface abnormalities that may affect tear film distribution or treatment (e.g. pterygium, anterior membrane dystrophy, etc.) 11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, notching of lid margin, distichiasis, trichiasis) 12. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. 13. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area 14. Ocular trauma within 3 months prior to enrollment 15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis 16. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation 17. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea 18. Punctal occlusion or punctal plug placement within 30 days prior to enrollment 19. Systemic diseases resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) 20. Allergies to silicone tissue adhesives 21. Use of Restasis or Xiidra within 60 days prior to enrollment. Subject must also be willing to remain off these drugs for the duration of the study. 22. Use of antihistamines (oral or topical) within 10 days prior to enrollment. Subject must also be willing remain off antihistamines for the duration of the study. 23. Subject is currently on a systemic medication(s) (other than anti-histamines) that is known to cause ocular dryness (e.g. diuretics, anti-hypertensives, anti-depressants, hormone therapy) and whose dose of this medication(s) has not been stable within 30 days prior to enrollment. There must be no anticipated adjustments to the dose of these medications for the duration of the trial. 24. Subject has taken or is currently taking Accutane 25. Subject requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within 30 days prior to enrollment 26. Subject is currently using Retin A or Latisse 27. Participation in another ophthalmic clinical trial within one year prior to enrollment. Subject must also be willing to refrain from another ophthalmic study for the duration of the study. 28. 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. Subjects who are pregnant or nursing or have active, wet macular degeneration are excluded.

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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

  • Arlington Eye Physicians

    Arlington Heights, Illinois, 60005, United States

  • Eye Research Institute

    Newport Beach, California, 92663, United States

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517, United States

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