A novel system, TearCare^®, for the treatment of the signs and symptoms of dry eye disease

Figures & data

Figure 1 Photograph of the iLid devices.

Note: The iLid devices are affixed to the external surface of each eyelid along the eyelid margin to target the terminal ducts of the meibomian glands with controlled delivery of thermal energy to the eyelids (41°C–45°C).

Figure 2 The TearCare^® System controller unit.

Note: The clinician initiates therapy by pressing the On/off button. Once therapy is initiated, the controller monitors and regulates the delivery of thermal energy to the eyelids during the 12-minute procedure.

Table 1 Baseline demographics of the study population

Parameter	Overall (n=24)	TearCare^® system (n=12)	Warm compress (n=12)
Age (years)
Mean (SD)	67.7 (13.5)	69.3 (11.5)	66.1 (15.1)
Range	29.7–89.8	51.2–89.8	29.7–85.8
≥65 years, n (%)	14 (58)	7 (58.3)	7 (58.3)
≥75 years, n (%)	7 (29)	3 (25.0)	4 (33.3)
Sex, n (%)
Female	24 (100)	12 (100)	12 (100)
Male	0 (0)	0 (0)	0 (0)
Race, n (%)
White	24 (100)	12 (100)	12 (100)
Ethnicity, n (%)
Not Hispanic or Latino	24 (100)	12 (100)	12 (100)

Table 2 Baseline characteristics of the 2 study groups

End point – mean (SD)	TearCare^® system (n=12)	Warm compress (n=12)
TBUT (sec)	3.1 (0.8)	3.3 (1.0)
OSDI score	41.0 (18.4)	33.0 (19.9)
Meibomian gland score	6.3 (3.6)	9.0 (4.3)*
Corneal staining score	3.5 (1.8)	3.4 (2.9)
Conjunctival staining score	3.7 (2.5)	3.0 (3.4)
SPEED score	15.7 (5.2)	14.4 (3.8)
SANDE score	64.9 (25.9)	55.9 (31.5)
Visual acuity (logMAR)	0.1 (0.1)	0.1 (0.1)
Additional baseline data
TBUT <10 seconds in at least 1 eye, n (%)	12 (100)	12 (100)
Schirmer (mm), mean (SD)	9.5 (10.2)	15.2 (12.2)
Schirmer ≤10 mm in at least 1 eye, n (%)	9 (75)	8 (67)

Notes: Unless otherwise labeled, the p-value was not significant.

* p-value between groups =0.02.

Abbreviations: OSDI, ocular surface disease index; SANDE, Symptom Assessment in Dry Eye; SPEED, Standard Patient Evaluation for Eye Dryness; TBUT, tear breakup time.

Figure 3 Primary efficacy end point – TBUT results.

Notes: The mean (±SD) values for the TBUT measured in seconds are shown for the TearCare treatment group (solid circles) and the warm compress group (open squares). Significant improvements in the comparison between groups of the change from baseline (increases in the score from baseline) in TBUT were observed at each post-baseline visit for the TearCare group. *p<0.001.
Abbreviation: TBUT, tear breakup time.

Table 3 Mean total corneal staining scores by treatment group and visit

Study visit	TearCare^® system		Warm compress
	Mean (SD) (n=12)	Difference from baseline (SD)	Mean (SD) (n=12)	Difference from baseline (SD)
Baseline	3.5 (1.8)	N/A	3.4 (2.9)	N/A
2 weeks	0.2 (0.4)	−3.3 (1.8)*	3.5 (2.7)	0.1 (2.3)
4 weeks	0.2 (0.4)	−3.3 (1.8)*	3.2 (2.6)	−0.2 (1.7)
3 months	0.2 (0.4)	−3.2 (1.9)*	3.8 (2.5)	0.4 (1.6)
6 months	0.5 (0.7)	−3.3 (1.8)*	3.2 (2.8)	0.1 (2.3)

Notes: Decreasing score indicates improvement. p-values indicate the comparison of the change from baseline between groups.

* p-value <0.001.

Table 4 Mean conjunctival staining scores by treatment group and visit

Study visit	TearCare^® system		Warm compress
	Mean (SD) (n=12)	Difference from baseline	Mean (SD) (n=12)	Difference from baseline
Baseline	3.7 (2.5)	N/A	3.0 (3.4)	N/A
2 weeks	0.2 (0.4)	−3.4 (2.3)*	4.3 (5.4)	1.3 (2.4)
4 weeks	0.1 (0.3)	−3.6 (2.4)*	4.1 (3.5)	1.2 (2.6)
3 months	0.2 (0.6)	−3.4 (2.3)*	5.2 (5.9)	2.3 (2.9)
6 months	0.3 (0.7)	−3.3 (2.5)*	3.2 (3.1)	0.2 (1.7)

Notes: Decreasing score indicates improvement. p-values indicate the comparison of the change from baseline between groups.

* p-value <0.001.

Figure 4 Secondary efficacy end points – questionnaire results.

Notes: The mean (±SD) values for the subject responses to questionnaires evaluating the symptoms of dry eye are presented for the SPEED (A), the OSDI (B), and the SANDE questionnaires (C). Results are shown for the TearCare treatment group (solid circles) and the warm compress group (open squares). On comparison between the groups, significant improvements with change of mean scores from baseline (decreases in the score from baseline) are noted with the p-values for each panel.
Abbreviations: OSDI, ocular surface disease index; SANDE, symptom assessment in dry eye; SPEED, Standard Patient Evaluation for Eye Dryness.

Figure 5 Secondary efficacy end point – meibomian gland score results.

Notes: The mean (±SD) values for the meibomian gland assessment scores are shown for the TearCare treatment group (solid circles) and the warm compress group (open squares). On comparison between the groups, significant improvements from baseline (increasing score from baseline) in meibomian gland scores were observed at each post-baseline visit for the TearCare group. *p<0.001.