TearCare MGXâ„¢ System With and Without Warming Hold (NCT07365735) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
TearCare MGXâ„¢ System With and Without Warming Hold
United States20 participantsStarted 2026-03-17
Plain-language 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).
Who can participate
Age range22 Years
SexALL
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Inclusion criteria
✓. Male or female subjects, 22 years of age or older
✓. Reports dry eye symptoms within the past 6 months
✓. OSDI score of 23 to 79
✓. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
✓. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
✓. Best corrected visual acuity of 20/100 or better, OU.
✓. Willing and able to comply with the study procedures and follow-up
✓. Understands and signs the informed consent.
Exclusion criteria
✕. Use of:
✕. Cyclosporine, Xiidra, or serum tears within 60 days prior to Screening;
✕. Antihistamines (oral or topical) within 7 days prior to Screening;
✕. Oral tetracyclines or azithromycin within 30 days prior to Screening;
✕. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to Screening
✕
What they're measuring
1
Mean difference between eyes in Meibomian Gland Secretion Score (MGSS)
Timeframe: MGSS used to calculate the difference in MGSS between eyes is obtained post-treatment at the procedure visit (Day 0).
✕. Office-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \[LipiFlow\], iLux etc.) within 12 months prior to Screening either as part of routine care or clinical investigation;