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NOT YET RECRUITING
NCT07579156
NA

TearCare in Young Adults

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-11-01

Completion Date

2027-12-01

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DEVICE

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 comprises a reusable Smart-hub and single-use Smart-lids. The single-use Smart-lid 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 Smart-lids allows them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. The Smart-lids are connected to the Smart-hub. When attached to the Smart-hub, the Smart-lids deliver thermal energy (i.e., heat) to the eyelids. Embedded software and a closed loop sensor system ensure that the temperature delivered at the eyelids is maintained within a precise range.

Locations (1)

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

Birmingham, Alabama, United States