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| ID | Type | Description | Link |
|---|---|---|---|
| Sight Sciences, Inc. | Other Identifier | Sight Sciences, Inc. |
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| Name | Class |
|---|---|
| Sight Sciences, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| OSDI AT 4 WEEKS | The OSDI is a 12-item questionnaire that queries a patient's symptom frequency, situational context, and environmental triggers. | 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) | Baseline to Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sindhu Gurrala, BDS, MPH | Contact | 205-975-3881 | SOeyes@uab.edu | |
| UAB Optometry Clinical Research (205) 934-6734 | Contact | SOeyes@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jillian F Ziemanski, OD, PhD, FAAO | The University of Alabama at Birmingham, School of Optometry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility | Birmingham | Alabama | 35294 | United States |
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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| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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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.
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All participants, investigators, and study staff will know the treatment being administered. No masking or blinding procedures are implemented.
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