Meibomian Gland Dysfunction (Disorder)NCT07579156
TearCare in Young Adults
A study testing TearCare® in people with Meibomian Gland Dysfunction (Disorder), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Meibomian Gland Dysfunction (Disorder)
- What is being tested?
- TearCare®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years but <30 years of age
- Non-invasive Keratograph break-up time (NIKBUT) <10 seconds in at least one eye
- Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid
- OSDI ≥23
Who cannot join
- Contact lens wear within two weeks of study enrollment or planned during study period
- Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye
- Previous or current diagnosis of any autoimmune condition
- Use of any of the following medications within 60 days of enrollment:
- Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions)
- Xiidra®
Show all 26Show fewer
- Miebo®
- Tyrvaya®
- Tryptyr®
- Use of topical ocular steroids within 30 days of enrollment
- Use of any other topical ophthalmic drop, excluding artificial tears, within 7 days
- Use of oral tetracyclines or oral azithromycin within 30 days
- Present or past use of oral isotretinoin
- Any of the following procedural treatments for MGD in the past:
- LipiFlow®
- TearCare®
- iLux®
- Intense pulsed light (IPL)
- Previous intraocular surgery within 6 months of enrollment
- Previous refractive surgery within 2 years of enrollment
- Current or planned pregnancy during the study period
- Current or planned lactation during the study period
- Females of childbearing potential who are not using effective contraception
- Dose modification of oral antihistamines or antidepressants within 30 days of enrollment
- Current enrollment or enrollment within 60 days in any other study of an investigational drug or device
- Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
UAB Optometry Clinical Research (205) 934-6734 contact
United States1 site
University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility
Birmingham, Alabama, 35294
Sindhu Gurrala, BDS, MPH, 205-975-3881, sgurral2@uab.edu
Jillian F Ziemanski, OD, PhD, FAAO
About this study
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
Read the detailed description
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment.
Co-primary efficacy endpoints include change from baseline in non-invasive keratograph break-up time (NIKBUT) at Day 28 and change from baseline in ocular surface disease index (OSDI) at Day 28. Secondary endpoints include the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. Exploratory endpoints include change from baseline in Dry Eye-Related Quality of Life Score (DEQS) at Day 28. The primary safety endpoint is the incidence of adverse effects that are probably or definitely related to the intervention.
The study population will include 45 young adults with clinically significant MGD (30 participants who are ≥18 to <22 years of age and 15 participants who are ≥22 to <30 years of age). The study duration is 4 weeks. TearCare® eyelid warming and manual gland expression will be performed once at Visit 1.
- Conditions
- Meibomian Gland Dysfunction (Disorder)
- Being tested
- TearCare®
- Keywords
- Meibomian Gland Dysfunction, TearCare, Ocular Surface Inflammation, Dry Eye Disease
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TearCare®Device
The TearCare system is designed to deliver controlled, precise heat to the tarsal plates and underlying MGs of the eyelids for 15 minutes. The TearCare system is comprised of a reusable SmartHub and single-use SmartLids. The single-use SmartLid pair comprises four flexible, sensor-controlled strips that adhere to each of the four eyelids. They contain flexible circuits, sensors, and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The SmartLids are connected to the SmartHub. When attached to the SmartHub, the SmartLids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensures that the temperature delivered at the eyelids is maintained within a precise range.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TearCare® eyelid warming and manual gland expression performed once at Visit 1 and followed for 4 weeks. All participants will undergo standardized ocular assessments including OSDI questionnaires, non-invasive keratograph break-up time, Visual acuity high contrast, Biomicroscopy, posterior lid margin hyperemia, Fluorescein tear breakup time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy with lissamine green, Surveys - DEQS, SANDE, Screen time-use, Lipview 11 lipid imaging, Keratograph R-scan, Keratogrpahy meibography, meiobomian gland expression by meibomian gland evaluator. Receives: Device: TearCare® |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI AT 4 WEEKS
The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers.
Measured: Baseline to 4 weeks
Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks
The secondary efficacy endpoint is the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. A clinically meaningful improvement in NIKBUT is defined as at least a 2-second increase versus baseline or at least a 50% increase15 if baseline NIKBUT <4 s. A clinically meaningful improvement in OSDI is defined as a decrease of 4.5 units for mild to moderate disease16 (OSDI ≥ 13 by <33 at baseline) or 7.3 units for severe disease16 (OSDI ≥ 33 at baseline)
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meibomian Gland Dysfunction (Disorder)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Model description
- This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Sight Sciences, Inc.
- Responsible party
- Principal investigator, Jillian Ziemanski, University of Alabama at Birmingham
- Investigators
- Jillian F Ziemanski, OD, PhD, FAAO, Principal investigator, The University of Alabama at Birmingham, School of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579156
- Sponsor's protocol ID
- 300016555
- Other IDs
- Sight Sciences, Inc.
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside of the study team, sponsor, or regulatory agencies. Participant data will be used only for analysis related to this study and may be reviewed by authorized representatives of the sponsor (Sight Sciences, Inc.), the University of Alabama at Birmingham Institutional Review Board (IRB), and regulatory authorities as required by law. De-identified summary results may be shared in aggregate form in publications or presentations, but no individual-level data will be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TearCare in Young Adults
- ClinicalTrials.gov ID
- NCT07579156
- Acronym / sponsor ID
- 300016555
- Conditions
- Meibomian Gland Dysfunction (Disorder)
- Keywords
- Meibomian Gland Dysfunction, TearCare, Ocular Surface Inflammation, Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Sight Sciences, Inc.
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
Detailed description
This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment.
Co-primary efficacy endpoints include change from baseline in non-invasive keratograph break-up time (NIKBUT) at Day 28 and change from baseline in ocular surface disease index (OSDI) at Day 28. Secondary endpoints include the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. Exploratory endpoints include change from baseline in Dry Eye-Related Quality of Life Score (DEQS) at Day 28. The primary safety endpoint is the incidence of adverse effects that are probably or definitely related to the intervention.
The study population will include 45 young adults with clinically significant MGD (30 participants who are ≥18 to <22 years of age and 15 participants who are ≥22 to <30 years of age). The study duration is 4 weeks. TearCare® eyelid warming and manual gland expression will be performed once at Visit 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: TearCare®TearCare® eyelid warming and manual gland expression performed once at Visit 1 and followed for 4 weeks. All participants will undergo standardized ocular assessments including OSDI questionnaires, non-invasive keratograph break-up time, Visual acuity high contrast, Biomicroscopy, posterior lid margin hyperemia, Fluorescein tear breakup time, corneal fluorescein staining, conjunctival staining with lissamine green, lid wiper epitheliopathy with lissamine green, Surveys - DEQS, SANDE, Screen time-use, Lipview 11 lipid imaging, Keratograph R-scan, Keratogrpahy meibography, meiobomian gland expression by meibomian gland evaluator. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥18 years but <30 years of age
- Non-invasive Keratograph break-up time (NIKBUT) <10 seconds in at least one eye
- Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid
- OSDI ≥23
Key exclusion criteria (26 listed)
- Contact lens wear within two weeks of study enrollment or planned during study period
- Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye
- Previous or current diagnosis of any autoimmune condition
- Use of any of the following medications within 60 days of enrollment:
- Use of topical ocular steroids within 30 days of enrollment
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 |
|---|---|---|
| TearCare®The TearCare system is designed to deliver controlled, precise heat to the tarsal plates and underlying MGs of the eyelids for 15 minutes. The TearCare system is comprised of a reusable SmartHub and single-use SmartLids. The single-use SmartLid pair comprises four flexible, sensor-controlled strips that adhere to each of the four eyelids. They contain flexible circuits, sensors, and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The SmartLids are connected to the SmartHub. When attached to the SmartHub, the SmartLids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensures that the temperature delivered at the eyelids is maintained within a precise range. | Device | Treatment |
Primary outcome
OSDI AT 4 WEEKS
Time frame: Baseline to 4 weeks
The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers.
Non-Invasive Keratograph Break-Up Time(NIKBUT) at 4 weeks
Time frame: Baseline to Week 4
The secondary efficacy endpoint is the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. A clinically meaningful improvement in NIKBUT is defined as at least a 2-second increase versus baseline or at least a 50% increase15 if baseline NIKBUT <4 s. A clinically meaningful improvement in OSDI is defined as a decrease of 4.5 units for mild to moderate disease16 (OSDI ≥ 13 by <33 at baseline) or 7.3 units for severe disease16 (OSDI ≥ 33 at baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside of the study team, sponsor, or regulatory agencies. Participant data will be used only for analysis related to this study and may be reviewed by authorized representatives of the sponsor (Sight Sciences, Inc.), the University of Alabama at Birmingham Institutional Review Board (IRB), and regulatory authorities as required by law. De-identified summary results may be shared in aggregate form in publications or presentations, but no individual-level data will be made publicly available.
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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.
UAB Optometry Clinical Research (205) 934-6734 contact
Jillian F Ziemanski, OD, PhD, FAAO principal investigator
The University of Alabama at Birmingham, School of Optometry
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 Meibomian Gland Dysfunction (Disorder), run by University of Alabama at Birmingham 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 4 inclusion and 26 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: opening soon, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sindhu Gurrala, BDS, MPH (205-975-3881, SOeyes@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI AT 4 WEEKS (time frame: Baseline to 4 weeks). The study lists 2 primary outcomes in all. 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 11 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.