NCT07365735

A Prospective, Randomized, Controlled Trial of the TearCare MGX™ System With and Without Warming Hold

A Prospective, Randomized, Controlled Trial of the TearCare MGX™ System With and Without Warming Hold (Xtend)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sight Sciences, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

TearCare is an office-based thermal therapeutic eyelid technology cleared by the US Food and Drug Administration for the treatment of evaporative dry eye disease due to meibomian gland dysfunction. In this randomized study, TearCare procedures using the TearCare MGX System (study device) with the extended Warming hold feature will be compared with TearCare procedures using the TearCare MGX System without the Warming hold (control group).

Detailed description

This study will collect data to assess the clinical utility of the Warming Hold period. The TearCare MGX Warming hold is a 10-minute period beyond completion of the Core Therapy time that serves to preserve elevated temperature by outputting only enough energy to maintain heat at the lowest setting of the system. At the minimum warmth setting the SmartLid device surfaces provide a steady state temperature of 39.0°C. This is a prospective, randomized, assessor-masked, single-center, non-significant risk (NSR) study. To reduce potential bias in the study, study staff performing the endpoint assessments will be masked. Subjects will also be masked as to group assignment. In this randomized study, TearCare procedures using the TearCare MGX System (study device) with the extended Warming hold feature will be compared with TearCare procedures using the TearCare MGX System without the Warming hold (control group). TearCare procedures in this study will include an in-office eyelid debridement, 15-minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects will receive one in-office TearCare procedure at the Procedure Visit.

Conditions

• Meibomian Gland Dysfunction (Disorder)

Interventions

Type	Name	Description
DEVICE	localized heat therapy	Blink-assisted, open eye therapy. Heat (45 degrees C) applied for 15 minutes to the upper and lower eyelids, followed by manual expression of the meibomian glands.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study