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Warm eyelid treatment could replace daily drops for dry eye sufferers

NCT ID NCT04795752

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a device that warms and massages the eyelids (TearCare) works better than prescription eye drops (Restasis) for dry eye disease. 345 adults with dry eye and blocked eyelid glands were randomly assigned to either an in-office TearCare procedure or twice-daily Restasis drops for 6 months. The goal was to see which treatment better improves tear film stability and reduces dry eye symptoms.

What this could mean

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

Active substance
TearCare System (thermal eyelid device) and Restasis (cyclosporine eye drops)
What this could lead to
If successful, this could offer a convenient in-office procedure as an alternative to daily eye drops for managing dry eye symptoms.
What could go wrong
This is a completed trial, but results may show only modest improvement over existing treatments. The device requires multiple in-office visits and may not work for everyone.

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

345 people

The number who actually took part.

Started

Apr 2021

Finished

Sep 2024

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: * At least 22 years of age * Reports dry eye symptoms within the past 3 to 6 months * Reports having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms. * Schirmer tear test (with anesthesia) ≥1 to ≤10 mm in 5 minutes * OSDI Score of 23-79 * TBUT of ≥1 to ≤7 seconds in both eyes * Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye. * At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp. * Best corrected visual acuity of 20/100 or better in both eyes. * Willing and able to comply with the study procedures and follow-up * Willing and able to provide informed consent * English-speaking Exclusion Criteria: * Use of any of the following medications: 1. Cyclosporine (Restasis, Cequa etc.) or Xiidra within 60 days prior to enrollment; 2. Antihistamines (oral or topical) within 10 days prior to enrollment; 3. Systemic medication(s) (other than antihistamines) 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; 4. Accutane (at any time); 5. Oral tetracyclines or azithromycin within 30 days prior to enrollment; or 6. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti- inflammatory medications within 30 days prior to enrollment. * 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 enrollment either as part of routine care or clinical investigation; 2. Meibomian gland expression within 6 months prior to enrollment; 3. Blephex or debridement within 3 months prior to enrollment is an exclusion; 4. Punctal occlusion or punctal plugs. Investigators can choose to remove the punctal plugs 15 days prior to enrollment; 5. Use of TrueTear device within the past 2 weeks. (Subjects must refrain from using the TrueTear device for the duration of the study.); or 6. Any history of meibomian gland probing * 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. * Contact lens use within the past 2 weeks. * History of Ocular Herpes Simplex or Ocular Herpes Zoster * Any active, clinically significant ocular or peri-ocular infection or inflammation * Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to enrollment * Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded. * Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis). * Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.

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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

  • Cincinnati Eye Institute

    Edgewood, Kentucky, 41017, United States

  • Doctor My Eyes

    Scottsdale, Arizona, 85254, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Harvard Eye Associates

    Laguna Hills, California, 92653, United States

  • Jackson Eye

    Lake Villa, Illinois, 60046, United States

  • Kentucky Eye Institute

    Lexington, Kentucky, 40517, United States

  • Loh Ophthalmology Associates

    Miami, Florida, 33143, United States

  • Parkhurst NuVision

    San Antonio, Texas, 78229, United States

  • Scripps Health

    La Jolla, California, 92037, United States

  • University of Pittsburg-Ophthalmology Dept

    Pittsburgh, Pennsylvania, 15213, United States

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108, United States

  • Vantage Eye Care

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Vision Institute

    Colorado Springs, Colorado, 80907, United States

  • Vita Eye Clinic

    Shelby, North Carolina, 28150, United States

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