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Warm compress rival? TearCare device tested for dry eye
NCT ID NCT03006978
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small pilot study tested the TearCare system, a device that applies heat to the eyelids, in 24 adults with dry eye disease. The goal was to see if it safely improves tear stability and oil gland function compared to a warm compress. Results were measured after one month.
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 (heat-based eyelid treatment)
- What this could lead to
- If it works, this could offer a new way to ease dry eye symptoms by improving oil gland function.
- What could go wrong
- This is a very small pilot study with only 24 people, so results may not apply to everyone. The device may not work better than a warm compress.
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
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24 people
The number who actually took part.
- Started
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Jan 2017
- Finished
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Mar 2018
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * At Least 18 Years of age * Reports dry eye symptoms within 3 months of the screening exam with a SPEED score \>=6 * Schirmer 1 value of \<10 mm in at least one eye or a Tear Breakup time \<10 seconds in at least one eye * Willing to comply with the study, procedures, and follow-up * Willing and able to provide consent Exclusion Criteria: * Any active ocular or peri-ocular infection or inflammation * Recurrent eye inflammation within the past 3 months * Ocular surgery, oculoplastic surgery, ocular injury, Ocular Herpes Simplex, or Herpes Zoster * Ocular surface abnormalities that may affect tear film distribution or treatment * Abnormal eyelid function in either eye * Diminished or abnormal facial, periocular, ocular or corneal sensation * Ocular surface abnormalities such as corneal epithelial defects, ulcers, corneal dystrophies * Systemic diseases resulting in dry eye (e.g. Sjogren's syndrome) * Allergies to silicone tissue adhesives * An absence or fibrosis of the Meibomian glands (e.g. ectodermal dysplasia). * Unwillingness to abstain for the duration of the study from systemic medication known to cause ocular dryness (e.g. Accutane, antihistamines, etc.) * Anyone who requires chronic use (i.e. for any portion of the study) of topical ophthalmic antibiotics, steroids, non-steroidal anti-inflammatory medications or who has been on any of these medications within the past 30 days. * Unwillingness to washout and remain off certain dry eye medications for the duration of the study. * Participation in another ophthalmic clinical trial within the past 30 days * Co-existing conditions that could interfere with the assessment of safety or efficacy of treatment (e.g. macular disease, pregnancy, nursing, etc.)
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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
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Central Eye Care, Ltd.
Arlington Heights, Illinois, 60005, United States
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