TearCare MGX™ System With and Without Warming Hold
NCT07365735 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-04-24
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).
Conditions
- Meibomian Gland Dysfunction (Disorder)
Interventions
- 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.
Sponsors & Collaborators
-
Sight Sciences, Inc.
lead INDUSTRY
Principal Investigators
-
Thomas Chester, OD · Cleveland Eye Clinic
-
Jaime Dickerson, PhD · Sight Sciences, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-17
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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