Dry Eye SyndromesNCT03502447
Randomized Study of the Safety and Effectiveness of the TearCare System for the Signs and Symptoms of Dry Eye Disease
A study testing TearCare and Warm Compress and Lid Massage in people with Dry Eye Syndromes, run by Sight Sciences, Inc. at 6 sites in United States.
Trial summary
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- TearCare and Warm Compress and Lid Massage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Apr 2018to 4 Dec 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with dry eye disease
- Signs and symptoms of dry eye disease
- Best corrected visual acuity 20/100 or better
- Willing and able to comply with study procedures
- Willing and able to provide consent
Who cannot join
- Active ocular infection or inflammation
- History of eyelid, conjunctiva or corneal surgery within the past year.
- Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
- Contact lens wearer
- Significant ocular surface or eyelid abnormalities, recent ocular trauma
- Certain corneal surface abnormalities
- Use of medications for treatment of dry eye or medications that cause dry eye
- Systemic disease that results in dry eye
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Harvard Eye Associates
Laguna Hills, California, 92653
Center for Excellence in Eye Care
Miami, Florida, 33176
Eye Research Foundation
Newport Beach, California, 92663
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.
NOTE: All sites have been selected for this study.
Read the detailed description
This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months.
All subjects will complete an informed consent form indicating their voluntary participation in the study.
Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.
- Conditions
- Dry Eye Syndromes
- Being tested
- TearCare, Warm Compress and Lid Massage
- 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
TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
Warm Compress and Lid MassageDevice
Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.
| Study group | Role | What they receive |
|---|---|---|
| TearCare | Experimental | TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. Receives: Device: TearCare |
| Warm Compress & Lid Massage | Active comparator | Subjects will perform warm compress and lid massage at home daily. Receives: Device: Warm Compress and Lid Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Tear Break-Up 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. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.
Measured: 1 month
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start20 Apr 2018
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Why it stopped: Sponsor chose to change the study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaime Dickerson, PhD, Study director, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502447
- Sponsor's protocol ID
- 05474
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2018
- Last updated
- 29 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
- ClinicalTrials.gov ID
- NCT03502447
- Acronym / sponsor ID
- 05474
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor chose to change the study design.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Posted 29 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.
NOTE: All sites have been selected for this study.
Detailed description
This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months.
All subjects will complete an informed consent form indicating their voluntary participation in the study.
Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TearCare | Experimental | Device: TearCareTearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands. |
| Warm Compress & Lid Massage | Active comparator | Device: Warm Compress and Lid MassageSubjects will perform warm compress and lid massage at home daily. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with dry eye disease
- Signs and symptoms of dry eye disease
- Best corrected visual acuity 20/100 or better
- Willing and able to comply with study procedures
- Willing and able to provide consent
Key exclusion criteria (8 listed)
- Active ocular infection or inflammation
- History of eyelid, conjunctiva or corneal surgery within the past year.
- Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
- Contact lens wearer
- Significant ocular surface or eyelid abnormalities, recent ocular trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TearCareTearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands. | Device | TearCare |
| Warm Compress and Lid MassageSubjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage. | Device | Warm Compress & Lid Massage |
Primary outcome
Mean Change in Tear Break-Up Time From Baseline to Month 1
Time frame: 1 month
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. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.
1 secondary outcome
Mean Change in OSDI Score From Baseline to Month 1
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Dickerson, PhD study director
Sight Sciences, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TearCare and Warm Compress and Lid Massage in people with Dry Eye Syndromes, run by Sight Sciences, Inc. at 6 sites 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 8 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: stopped early, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 29 Sep 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 Break-Up Time From Baseline to Month 1 (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.