Dry Eye SyndromesNCT03804502
Pilot Study of TearCare System - Long-Term Extension
A study testing TearCare in people with Dry Eye Syndromes, run by Sight Sciences, Inc. at 1 site in United States.
Trial summary
The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- TearCare
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2018to 21 May 2019
- 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
- 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
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.
About this study
The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.
Read the detailed description
This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study (NCT03006978). In the initial study, subjects with dry eye disease (DED) were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point.
- Conditions
- Dry Eye Syndromes
- Being tested
- TearCare
- 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
The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
| Study group | Role | What they receive |
|---|---|---|
| TearCare | Experimental | Subjects will receive one TearCare treatment at the baseline visit Receives: Device: TearCare |
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 Extension Study 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 resulting in a single TBUT value for each subject (n=12).
Measured: 1 month
Secondary outcomes (6)
Mean Change in Meibomian Gland Score From Extension Study 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 (worst)-45 (best) 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 positive value for change is an improvement
Measured: 1 month
Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1
The Standard Patient Evaluation for Eye Dryness II (SPEED II) questionnaire is a well-validated instrument and widely used assessment tool for dry eye indications. The SPEED II questionnaire was used to evaluate the symptoms of study subjects. The SPEED II survey measures the severity (0-4 scale) and frequency (0-3 scale) of 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 (range 0 [best] to 7 [worst]). The reported value is the mean of the change for all subjects. A negative result indicates improvement.
Measured: 1 month
Mean Change in OSDI Questionnaire Result From Extension Study 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
Mean Change in Corneal Staining From Extension Study Baseline to Month 1
Corneal (fluorescein) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 5 regions of the cornea using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the cornea were added to obtain a total score that ranged from 0 (best) to 15 (worst). The score for each eye of a subject was averaged. The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.
Measured: 1 month
Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1
Conjunctival (lissamine green) staining scores was recorded to assess the integrity of the ocular surface. The severity of staining was assessed and quantified using the National Eye Institute/Industry Grading System scoring 6 regions of the conjunctiva using a scale from 0 to 3 (normal-severe) for each region. The scores for the regions of the conjunctiva were added to obtain a total score that ranged from 0 (best) to 18 (worst). The score for each eye of a subject was averaged. The mean change from baseline to month 1 is the difference in the two scores. A negative result indicates improvement.
Measured: 1 month
Mean Change in SANDE Result From Extension Study Baseline to Month 1
The SANDE (Symptom Assessment iN Dry Eye) 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.
- First posted15 Jan 2019
- Study start17 Dec 2018
- Primary completion21 May 2019
- Study completion21 May 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Badawi, MD, Principal investigator, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804502
- Sponsor's protocol ID
- 06215
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2019
- Last updated
- 28 Oct 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 28 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of TearCare System - Long-Term Extension
- ClinicalTrials.gov ID
- NCT03804502
- Acronym / sponsor ID
- 06215
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Posted 28 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the long-term clinical utility, safety, and effectiveness of re-treatment with the TearCare™ System in adult patients with dry eye syndrome who had previously been treated with the TearCare System.
Detailed description
This was an extension of an initial 6-month, prospective, single-center, randomized, parallel-group pilot study (NCT03006978). In the initial study, subjects with dry eye disease (DED) were randomized to either a single TearCare® treatment or 4 weeks of daily warm compress therapy. The extension study involved retreatment of those subjects assigned to the TearCare® treatment group following the initial 6-month end point. At 6 months, subjects were evaluated for the clinical signs and symptoms of DED prior to retreatment in the extension study that would measure the safety, effectiveness, and durability of a TearCare® retreatment for another 6 months through a 12-month end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TearCare | Experimental | Device: TearCareSubjects will receive one TearCare treatment at the baseline visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| TearCareThe TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids. | Device | TearCare |
Primary outcome
Mean Change in Tear Break-Up Time From Extension Study 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 resulting in a single TBUT value for each subject (n=12).
6 secondary outcomes
Mean Change in Meibomian Gland Score From Extension Study Baseline to Month 1
Time frame: 1 month
Mean Change in SPEED II Questionnaire Result From Extension Study Baseline to Month 1
Time frame: 1 month
Mean Change in OSDI Questionnaire Result From Extension Study Baseline to Month 1.
Time frame: 1 month
Mean Change in Corneal Staining From Extension Study Baseline to Month 1
Time frame: 1 month
Mean Change in Conjunctival Staining From Extension Study Baseline to Month 1
Time frame: 1 month
Mean Change in SANDE Result From Extension Study 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 28 Oct 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.
David Badawi, MD principal investigator
Sight Sciences, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TearCare in people with Dry Eye Syndromes, 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 28 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 28 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 Break-Up Time From Extension Study 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 28 Oct 2025.