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Dry EyeNCT03006978

A Pilot Study of the TearCare System in Adults With Dry Eye Disease

A study testing TearCare and Warm Compress in people with Dry Eye, run by Sight Sciences, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a small, pilot study intended to determine the feasibility of this product. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dry Eye
What is being tested?
TearCare and Warm Compress
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jan 2017to Mar 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Central Eye Care, Ltd.

    Arlington Heights, Illinois, 60005

Other trials in United States

About this study

Official title: A Prospective, Single-center, Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare System in Adults With Dry Eye Disease TearCare Pilot Study)

This is a small, pilot study intended to determine the feasibility of this product.

Read the detailed description

The objective of this study was to evaluate the safety and effectiveness of the TearCare® System in adult patients with clinically significant dry eye disease (DED). This was a prospective, single-center, randomized, parallel-group, clinical trial. Subjects with DED were randomized to either a single TearCare treatment conducted at the clinic or 4 weeks of daily warm compress (WC) therapy. The TearCare procedure consisted of 12 minutes of thermal eyelid treatment immediately followed by manual expression of the meibomian glands. WC therapy consisted of once daily application of the compresses to the eyelids for 5 minutes. Subjects were followed until 6 months post-treatment.

Conditions
Dry Eye
Being tested
TearCare, Warm Compress
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TearCareDevice

  • Warm CompressDevice

Study groups in NCT03006978
Study groupRoleWhat they receive
TearCareExperimentalSubjects will receive a 12-minute treatment session with the TearCare System followed by manual expression of the meibomian glands. This procedure will be performed at the Baseline visit.
Receives: Device: TearCare
Warm CompressActive comparatorSubjects will apply a warm compress to the eyelids for 5 minutes daily for 4 weeks.
Receives: Device: Warm Compress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Tear Breakup Time From Baseline to Month 1

    The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. An increase in TBUT represents an improvement.

    Measured: 4 weeks

Secondary outcomes (4)

  1. Mean Change in Meibomian Gland Score From Baseline to Month 1

    Using a Korb Meibomian Gland Evaluator (TearScience), the meibomian gland assessment was conducted by evaluating the consistency of the secretions that were observed upon expression of meibomian glands in the nasal, central, and temporal regions of the lower eyelids. The central, consecutive 5 glands in each region were evaluated. The instrument was held at the eyelid margin for 10-15 seconds, and the secretions were graded on a 0-3 scale for each gland (0=no expression; 1=toothpaste; 2=cloudy; and 3=clear), with a 0-45 score range for each eye. The score for each eye of a subject was averaged. The change from baseline in the Meibomian Gland Score is the difference between the mean baseline value and the mean value at Month 1. A higher score represents an improvement.

    Measured: 1 month

  2. Change in SPEED (Standard Patient Evaluation of Eye Dryness) Questionnaire Score From Baseline

    The Standard Patient Evaluation for Eye Dryness (SPEED) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED questionnaire was used to evaluate 4 symptoms (1-dryness, grittiness, or scratchiness, 2-soreness or irritation, 3-burning or watering, 3-eye fatigue) of study subjects. The maximum score is 28 (worst) and the minimum possible is 0 (best). The SPEED survey measures the severity (0-4 scale - each symptom) and frequency (0-3 scale - each symptom) of these DED symptoms. The SPEED score was calculated by adding the total of the frequency and severity scores; a score of greater than or equal to 6 may be an indicator of DED. The reported value is the mean of the change for all subjects. A negative result indicates improvement.

    Measured: 1 Month

  3. Mean Change in OSDI Score From Baseline to Month 1

    The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire that assesses symptoms of ocular irritation associated with dry eye and the impact of these on vision-related activities. The OSDI score ranges from 0 (best possible) to 100 (worst possible). The change in OSDI questionnaire from baseline to Month 1 is the difference between the scores at the two timepoints. A negative value would indicate improvement and a positive value, a worsening. The reported value is the mean of the change for all subjects.

    Measured: 1 Month

  4. Mean Change in SANDE ( Symptom Assessment in Dry Eye) Questionnaire Score From Baseline to Month 1

    The SANDE instrument is a simple 2-item questionnaire, that focuses on the frequency and the severity of dry eye symptoms with each measured along a visual analog scale. SANDE, because of its simplicity, is often used in routine clinical practice. For the core questions, the frequency and severity scores are multiplied together, and the square root is taken to produce an overall SANDE score from 0 (best possible) to 100 (worst possible). The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.

    Measured: 1 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionFeb 2017
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03006978
Sponsor's protocol ID
05429
Status last verified
Sep 2025
First submitted
27 Dec 2016
Last updated
15 Oct 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Badawi D. A novel system, TearCare(R), for the treatment of the signs and symptoms of dry eye disease. Clin Ophthalmol. 2018 Apr 10;12:683-694. doi: 10.2147/OPTH.S160403. eCollection 2018.

    PubMed 29692600

Questions about this trial

What is this clinical trial studying?

A study testing TearCare and Warm Compress in people with Dry Eye, run by Sight Sciences, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Tear Breakup Time From Baseline to Month 1 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03006978, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.

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