A Prospective, Post-Market, Multicenter Trial (CHEETAH) Suggested TearCare^® System as a Safe and Effective Blink-Assisted Eyelid Device for the Treatment of Dry Eye Disease

Figures & data

Figure 1 Schematic of the clinical study plan.

Table 1 Baseline Disease Characteristics

Measures	N = 29
TBUT (seconds)	3.7 (1.1)
OSDI Score	54.9 (20.2)
Meibomian Gland Score	5.6 (4.0)
Corneal Staining Score	4.8 (2.5)
Conjunctival Staining Score	5.9 (3.2)
Contact Lens Use
Current	1 (3%)
Former	14 (48%)
Attempted	6 (21%)
Past History of Use	7 (24%)
History of Eyelid Surgery	3 (10%)
History of Dry Eye Treatment Other Than OTC
Debridement	2 (7%)
Restasis	4 (14%)
Xiidra	2 (7%)
Punctal Plugs	7 (24%)
Hours of Screen Use (Range 1–10)	4.3 (3.0)

Note: N = number of subjects.

Abbreviations: TBUT, tear break-up time; OSDI, Ocular Surface Disease Index; OTC, over-the-counter.

Figure 2 The TearCare System is effective in managing signs and symptoms of MGD and DED. Improvements were seen in (A) TBUT, (B) Meibomian Gland Score, (C) Corneal and Conjunctival Staining, and (D) OSDI scores. * and ** indicate p-values < 0.001.

Figure 3 Post-hoc subgroup analyses of the per-protocol population stratified by MGD severity by baseline MGSS scores in the subject’s worst eye (WE) above and below the median. Subjects with more severe dysfunction at baseline (orange) demonstrate a similar treatment effect benefit size in MGSS as subjects with less severe baseline dysfunction (blue) (A) that translates to greater relief of TBUT (B) and corneal staining (C) MGD-related DED signs at 1-month post-procedure. Error bars represent SEM.