TearCare in Young Adults

TearCare in Young Adults

This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant meibomian gland dysfunction (MGD). Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.

This study is a non-randomized, open-label, interventional trial of TearCare® eyelid warming and manual meibomian gland expression in young adults with clinically significant MGD. Intervention is with TearCare® performed at Visit 1. A single follow-up examination occurs at Day 28.

The primary objective is to evaluate the safety and efficacy of TearCare® in teenage and young-adult patients with MGD. A secondary objective includes a predictive analysis to determine which baseline clinical parameters best predict success with a TearCare treatment.

Co-primary efficacy endpoints include change from baseline in non-invasive keratograph break-up time (NIKBUT) at Day 28 and change from baseline in ocular surface disease index (OSDI) at Day 28. Secondary endpoints include the proportion of subjects with pre-defined baseline clinical characteristics who experience a clinically meaningful improvement in NIKBUT or OSDI. Exploratory endpoints include change from baseline in Dry Eye-Related Quality of Life Score (DEQS) at Day 28. The primary safety endpoint is the incidence of adverse effects that are probably or definitely related to the intervention.

The study population will include 45 young adults with clinically significant MGD (30 participants who are ≥18 to <22 years of age and 15 participants who are ≥22 to <30 years of age). The study duration is 4 weeks. TearCare® eyelid warming and manual gland expression will be performed once at Visit 1.

Inclusion Criteria:

1. Age ≥18 years but <30 years of age
2. Non-invasive Keratograph break-up time (NIKBUT) <10 seconds in at least one eye
3. Meibomian gland secretion score (MGSS) ≤23 for 15 glands in at least one eyelid
4. OSDI ≥23

Exclusion Criteria:

1. Contact lens wear within two weeks of study enrollment or planned during study period

2. Habitual visual acuity worse than 0.30 logMAR (Snellen equivalent of 20/40) in either eye

3. Previous or current diagnosis of any autoimmune condition

4. Use of any of the following medications within 60 days of enrollment:

   1. Topical ophthalmic cyclosporine (including but not limited to Restasis®, Cequa®, Vevye®, generic, or compounded versions)
   2. Xiidra®
   3. Miebo®
   4. Tyrvaya®
   5. Tryptyr®

5. Use of topical ocular steroids within 30 days of enrollment

6. Use of any other topical ophthalmic drop, excluding artificial tears, within 7 days

7. Use of oral tetracyclines or oral azithromycin within 30 days

8. Present or past use of oral isotretinoin

9. Any of the following procedural treatments for MGD in the past:

   1. LipiFlow®
   2. TearCare®
   3. iLux®
   4. Intense pulsed light (IPL)

10. Previous intraocular surgery within 6 months of enrollment

11. Previous refractive surgery within 2 years of enrollment

12. Current or planned pregnancy during the study period

13. Current or planned lactation during the study period

14. Females of childbearing potential who are not using effective contraception

15. Dose modification of oral antihistamines or antidepressants within 30 days of enrollment

16. Current enrollment or enrollment within 60 days in any other study of an investigational drug or device

17. Clinical opinion of the study doctor based on clinical examination and/or participant compliance with protocol requirements