TearCare MGX™ System With and Without Warming Hold

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

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).

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.

Inclusion Criteria:

1. Male or female subjects, 22 years of age or older
2. Reports dry eye symptoms within the past 6 months
3. OSDI score of 23 to 79
4. Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye.
5. At least 15 glands in each lower eyelid should be expressible, with a sterile cotton swab, at the slit lamp.
6. Best corrected visual acuity of 20/100 or better, OU.
7. Willing and able to comply with the study procedures and follow-up
8. Understands and signs the informed consent.

Exclusion Criteria:

1. Use of:

   1. Cyclosporine, Xiidra, or serum tears within 60 days prior to Screening;
   2. Antihistamines (oral or topical) within 7 days prior to Screening;
   3. Oral tetracyclines or azithromycin within 30 days prior to Screening;
   4. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, non-steroidal anti-inflammatory medications within 30 days prior to Screening
   5. Isotretinoin (e.g. Accutane) at any time.

2. Any of the following dry eye treatments:

   1. 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;
   2. Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);
   3. Meibomian gland expression within 6 months prior to Screening;
   4. Blephex or debridement within 3 months prior to Screening;
   5. 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;
   6. 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);
   7. Any history of meibomian gland probing.

3. History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.

4. Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.

5. 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.

6. Active hordeolum, stye, or chalazion at the time of the Screening visit.

7. History of Herpes Simplex or Herpes Zoster of the eye or eyelid.

8. Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation.

9. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to Screening.

10. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.

11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).

12. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area.

13. 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.

14. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea

15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis.

16. Ocular trauma within 3 months prior to Screening.

17. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation

18. Systemic diseases, in the Investigator's medical judgement, resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.)

19. Subject is currently using Retin A /Retin A derivatives.

20. Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.

21. Subject is currently using Latisse, Lash Boost or any other type of eyelash growth serum. Prostaglandin analog products such as Latisse should not be used within 30 days of the Screening visit.

22. Temporary false eyelashes, lash extensions, or any other type of false eyelash within 15 days of the Screening Visit.

23. Allergies to silicone tissue adhesives, acrylates and/or copper.

24. Subject has a pacemaker or implantable cardiac defibrillators (ICD).

25. Co-existing condition, either ocular or non-ocular that, in the judgement of the Investigator could affect the safety or effectiveness of treatment or the compliance of the subject to the protocol.