TABLE 1.
Baseline Demographics and Measurements of Study Endpoints for DED Signs and Symptoms in the Primary Analysis Population
| Parameter | TearCare Group | LipiFlow Group |
| Demographics | ||
| N (subjects) | 67 | 68 |
| Mean age [yr, (SD)] | 56.1 (13.7) | 52.3 (15.1) |
| Sex (%) | ||
| Women | 49 (73.1) | 42 (61.8) |
| Men | 17 (25.4) | 26 (38.2) |
| Race (%) | ||
| American Indian/Alaska Native | 0 (0.0) | 0 (0.0) |
| Asian | 2 (3.0) | 5 (7.4) |
| Black or African American | 3 (4.5) | 4 (5.9) |
| Indian | 0 (0.0) | 0 (0.0) |
| Iranian | 1 (1.5) | 0 (0.0) |
| Middle Eastern | 0 (0.0) | 1 (1.5) |
| Spanish | 1 (1.5) | 0 (0.0) |
| White | 59 (88.1) | 58 (85.3) |
| Dry eye sign endpoints | ||
| N (eyes) | 134 | 136 |
| Mean TBUT* (SD) | 4.6 (1.2) | 4.5 (1.0) |
| Mean total meibomian gland secretion score† (SD) | 6.5 (3.1) | 6.3 (2.7) |
| Mean corneal staining score total‡ (SD) | 2.5 (2.1) | 2.5 (2.3) |
| Mean conjunctival staining score total‡ (SD) | 4.1 (3.3) | 4.8 (3.1) |
| Mean # meibomian glands yielding any liquid (SD) | 5.6 (2.8) | 5.4 (2.6) |
| Mean # meibomian glands yielding clear liquid (SD) | 0.0 (0.2) | 0.0 (0.0) |
| Dry eye symptom endpoints | ||
| N (subjects) | 67 | 8 |
| Mean OSDI score§ (SD) | 52.0 (14.4) | 51.1 (16.1) |
| Mean SANDE score‖ (SD) | 68.4 (20.3) | 73.2 (16.1) |
| Mean eye dryness score¶ (SD) | 68.9 (22.1) | 68.9 (18.8) |
*
TBUT is the number of seconds between a blink and the appearance of a first dry spot or negative staining in the tear film.
†
Total Meibomian Gland Secretion Score is a weighted sum of the number of glands producing secretions, weighted by secretion quality.
‡
Corneal and conjunctival staining scores are the totals across all ocular regions.
§
Overall score from OSDI questionnaire.
‖
VAS from SANDE questionnaire. The SANDE score is calculated as the geometric mean of the SANDE severity VAS and SANDE frequency VAS.
¶
VAS measured subject's level of discomfort related to eye dryness, ranging from no discomfort to maximal discomfort.