TearCare in Young Adults

NCT07579156 | Not Yet Recruiting FDA Device

• 2 other identifiers: 300016555Sight Sciences, Inc.
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meibomian Gland Dysfunction (Disorder)

Keywords

Meibomian Gland Dysfunction; TearCare; Ocular Surface Inflammation; Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: TearCare®

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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®
• 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®

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Sight Sciences, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham, School of Optometry, Clinical Eye Research Facility

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Jillian F Ziemanski, OD, PhD, FAAO

  The University of Alabama at Birmingham, School of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sindhu Gurrala, BDS, MPH

CONTACT

205-975-3881; SOeyes@uab.edu

UAB Optometry Clinical Research (205) 934-6734

CONTACT

SOeyes@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants, investigators, and study staff will know the treatment being administered. No masking or blinding procedures are implemented.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model 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.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)