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Warm eyelid treatment shows promise for dry eye sufferers

NCT ID NCT03804502

Symptom relief Sponsor: Sight Sciences, Inc. Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 device, which warms the eyelids to melt clogged oil glands and improve tear quality. Twelve adults who had used the device before received another treatment. Researchers measured how long tears stayed on the eye and checked gland function. The goal was to see if repeat treatments are safe and helpful for 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 (device that warms eyelids to melt oil glands)
What this could lead to
If successful, this could provide a long-term, non-drug option for managing dry eye symptoms with repeat treatments.
What could go wrong
This is a very small pilot study with only 12 participants, so results may not apply to everyone. The device only eases symptoms temporarily and does not cure 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

12 people

The number who actually took part.

Started

Dec 2018

Finished

May 2019

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

18 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: * Previously enrolled in the TearCare arm of the TearCare Pilot Study * Reports dry eye symptoms within 3 months of the baseline examination with a Standard Patient Evaluation for Dryness (SPEED) score ≥ 6 * TBUT of \<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.

dry eye syndrome

As listed by the trial registrant

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

Dry eye syndromes

Contacts and locations

Locations

  • Central Eye Care

    Arlington Heights, Illinois, 60005, United States

More trials for these conditions

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