TearCare MGX™ System With and Without Warming Hold

Completed · Not applicable

Conditions studied: Meibomian Gland Dysfunction (Disorder)

In brief

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).

Key facts

Study ID

NCT07365735

Run by

Sight Sciences, Inc.

People needed

21

Starts

2026-03-17

Expected to finish

2026-05-19

Last updated by the study team

2026-06-05

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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;
• Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);
• Meibomian gland expression within 6 months prior to Screening;
• Blephex or debridement within 3 months prior to Screening;
• Punctal occlusion (including collagen, e.g. Soft Plug, UltraPlug, or crosslinked hyaluronic acid, e.g. Lacrifill) or punctal plugs within 15 days of the Screening visit;
• Use of tear neurostimulators (i.e., True Tear, iTear100, Tyrvaya) within 2 weeks of the baseline visit. (Subjects must refrain from using tear neurostimulators for the duration of the study);
• Any history of meibomian gland probing.
• History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.
• Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.
• Contact lens use within 2 weeks of the Procedure visit. Subjects presenting at the Screening visit using contact lenses must agree to discontinue use for a full 2 weeks (14 days) prior to the Procedure visit.
• Active hordeolum, stye, or chalazion at the time of the Screening visit.
• History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
• Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation.
• Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to Screening.
• Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.
• Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).
• Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.
• In the clinical judgement of the Investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a cotton swab.

Where it is running

• Cleveland Eye Clinic — Brecksville, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.