TearCare in Young Adults

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07579156
Status
Not Yet Recruiting

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Conditions

  • Meibomian Gland Dysfunction (Disorder)

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    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.

Primary Outcome Measure

OSDI AT 4 WEEKS [ Time Frame: Baseline to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, School of Optometry, Clinical Eye Research FacilityBirminghamAlabama35294
Sindhu Gurrala, BDS, MPH
[email protected]
205-975-3881
Jillian F Ziemanski, OD, PhD, FAAO (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility· Birmingham, AL

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