TearCare MGX™ System With and Without Warming Hold (NCT07365735) | Clinical Trial Compass
CompletedNot Applicable
TearCare MGX™ System With and Without Warming Hold
United States21 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 range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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
. Isotretinoin (e.g. Accutane) at any time.
. Any of the following dry eye treatments:
. 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;