Table 6.
Pre-Index n=600 | 3 Months (± 30 Days) Post-Index n=571 | 6 Months (± 30 Days) Post-Index n=534 | 12 Months (± 60 Days) Post-Index n=320 | |
---|---|---|---|---|
Corneal staining score [0–15] | ||||
Patients with documentation of sign assessment, n (% [95% CI]) | 111 (18.5 [15.5, 21.8]) | 14 (2.5 [1.3, 4.1]) | 15 (2.8 [1.6, 4.6]) | 31 (9.7 [6.7, 13.5]) |
Mean ± SD [median] (95% CI of mean) | 6.5 ± 3.9 [6.0] (5.8, 7.3) | 2.7 ± 2.3 [2.0] (1.4, 4.0) | 3.0 ± 3.0 [2.0] (1.3, 4.6) | 2.0 ± 1.7 [2.0] (1.3, 2.6) |
Schirmer score (mm) | ||||
Patients with documentation of sign assessment, n (% [95% CI]) | 82 (13.7 [11.0, 16.7]) | 5 (0.9 [0.3, 2.0]) | 7 (1.3 [0.5, 2.7]) | 17 (5.3 [3.1, 8.4]) |
Mean ± SD [median] (95% CI of mean) | 6.3 ± 10.8 [5.0] (3.9, 8.7) | 10.6 ± 1.7 [11.0] (8.5, 12.7) | 9.6 ± 2.8 [10.0] (7.0, 12.1) | 10.0 ± 3.2 [9.0] (8.4, 11.6) |
Tear film break up time (TFBUT) | ||||
Patients with documentation of sign assessment, n (% [95% CI]) | 237 (39.5 [35.6, 43.5]) | 36 (6.3 [4.5, 8.6]) | 34 (6.4 [4.4, 8.8]) | 46 (14.4 [10.7, 18.7]) |
Mean ± SD [median] (95% CI of mean) | 4.8 ± 3.1 [4.0] (4.4, 5.2) | 7.3 ± 3.1 [7.5] (6.2, 8.3) | 7.8 ± 2.1 [8.0] (7.0, 8.5) | 8.0 ± 2.8 [8.0] (7.2, 8.8) |
No sign assessment reported, n (% [95% CI]) | 249 (41.5 [37.5, 45.6]) | 522 (91.4 [88.8, 93.6]) | 481 (90.1 [87.2, 92.5]) | 248 (77.5 [72.5, 82.0]) |
Abbreviations: CI, confidence interval; DED, dry eye disease; SD, standard deviation; TFBUT, tear film break-up time.