Table 3.
Dry Eye Symptom Score (0–5, 6–10): Shift Table Between Subsequent Time Points on Day 1
| N=134 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline Score | n | 0 Hours | n/M (%) | Post-Baseline Scores | |||||
| 4 Hours | n/M (%) | 8 Hours | n/M (%) | ||||||
| |||||||||
| 0‒5 | 72 | 0‒5 | 69/72 (95.8) | 0‒5 | 66/69 (95.7) | 0‒5 | 65/66 (98.5) | ||
| 6‒10 | 1/66 (1.5) | ||||||||
| 6‒10 | 3/69 (4.3) | 0‒5 | 1/3 (33.3) | ||||||
| 6‒10 | 2/66 (66.7) | ||||||||
| 6‒10 | 3/72 (4.2) | 0‒5 | 3/3 (100.0) | 0‒5 | 3/3 (100.0) | ||||
| 6‒10 | 61 | 0‒5 | 41/41 (67.2) | 0‒5 | 32/41 (78.0) | 0‒5 | 27/32 (84.4) | ||
| 6‒10 | 5/32 (15.6) | ||||||||
| 6‒10 | 9/41 (22.0) | 0‒5 | 2/9 (22.2) | ||||||
| 6‒10 | 7/9 (77.8) | ||||||||
| 6‒10 | 19/61 (31.1) | 0‒5 | 14/19 (73.7) | 0‒5 | 12/14 (85.7) | ||||
| 6‒10 | 2/14 (14.3) | ||||||||
| 6‒10 | 5/19 (26.3) | 0‒5 | 1/5 (20.0) | ||||||
| 6‒10 | 4/5 (80.0) | ||||||||
| Missing | 1/61 (1.6) | 0‒5 | 1/1 (100.0) | 0‒5 | 1/1 (100.0) | ||||
| Missing | 1 | 0‒5 | 1/1 (100.0) | 0‒5 | 1/1 (100.0) | 6‒10 | 1/1 (100.0) | ||
| |||||||||
| Aqueous-deficient dry eye subtype (n=41) | |||||||||
| 0‒5 | 18 | 0‒5 | 16/18 (88.9) | 0‒5 | 15/16 (93.8) | 0‒5 | 15/15 (100.0) | ||
| 6‒10 | 1/16 (6.3) | 6‒10 | 1/1 (100.0) | ||||||
| 6‒10 | 2/18 (11.1) | 0‒5 | 2/2 (100.0) | 0‒5 | 2/2 (100.0) | ||||
| 6‒10 | 22 | 0‒5 | 15/22 (68.2) | 0‒5 | 12/15 (80.0) | 0‒5 | 9/12 (75.0) | ||
| 6‒10 | 3/12 (25.0) | ||||||||
| 6‒10 | 3/15 (20.0) | 6‒10 | 3/3 (100.0) | ||||||
| 6‒10 | 6/22 (27.3) | 0‒5 | 5/6 (83.3) | 0‒5 | 4/5 (80.0) | ||||
| 6‒10 | 1/5 (20.0) | ||||||||
| 6‒10 | 1/6 (16.7) | 6‒10 | 1/1 (100.0) | ||||||
| Missing | 1/22 (4.5) | 0‒5 | 1/1 (100.0) | 0‒5 | 1/1 (100.0) | ||||
| Missing | 1 | 0‒5 | 1/1 (100.0) | 0‒5 | 1/1 (100.0) | 6‒10 | 1/1 (100.0) | ||
| Evaporative dry eye subtype (n=44) | |||||||||
| 0‒5 | 26 | 0‒5 | 25/26 (96.2) | 0‒5 | 23/25 (92.0) | 0‒5 | 23/23 (100.0) | ||
| 6‒10 | 2/25 (8.0) | 0‒5 | 1/2 (50.0) | ||||||
| 6‒10 | 1/2 (50.0) | ||||||||
| 6‒10 | 1/26 (3.8) | 0‒5 | 1/1 (100.0) | 0‒5 | 1/1 (100.0) | ||||
| 6‒10 | 18 | 0‒5 | 14/18 (77.8) | 0‒5 | 9/14 (64.3) | 0‒5 | 7/9 (77.8) | ||
| 6‒10 | 2/9 (22.2) | ||||||||
| 6‒10 | 5/14 (35.7) | 0‒5 | 2/5 (40.0) | ||||||
| 6‒10 | 3/5 (60.0) | ||||||||
| 6‒10 | 4/18 (22.2) | 0‒5 | 3/4 (75.0) | 0‒5 | 3/3 (100.0) | ||||
| 6‒10 | 1/4 (25.0) | 0‒5 | 1/1 (100.0) | ||||||
| Mixed dry eye subtype (n=49) | |||||||||
| 0‒5 | 28 | 0‒5 | 28/28 (100.0) | 0‒5 | 28/28 (100.0) | 0‒5 | 27/28 (96.4) | ||
| 6‒10 | 1/28 (3.6) | ||||||||
| 6‒10 | 21 | 0‒5 | 12/21 (57.1) | 0‒5 | 11/12 (91.7) | 0‒5 | 11/11 (100.0) | ||
| 6‒10 | 1/12 (8.3) | 6‒10 | 1/1 (100.0) | ||||||
| 6‒10 | 9/21 (42.9) | 0‒5 | 6/9 (66.7) | 0‒5 | 5/6 (83.3) | ||||
| 6‒10 | 1/6 (16.7) | ||||||||
| 6‒10 | 3/9 (33.3) | 6‒10 | 3/3 (100.0 | ||||||
Notes: Full analysis set n is the number of patients on the respective category at the particular time point. M is the number of patients included in the respective category of the previous time point. Percentages are based on M. Baseline dry eye symptom assessment is obtained prior to dosing.