Table 5.
Best-corrected visual acuity in study eyes
| Safety parameter | All patients | Patients with corneal TEAE of interesta | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Bimatoprost implant 10 µg (n = 175) | Bimatoprost implant 15 µg (n = 176) | Timolol BID (n = 173) |
P Value Bim 10 µg vs. Timolol |
P Value Bim 15 µg vs. Timolol |
Bimatoprost implant 10 µg (n = 19) |
Bimatoprost implant 15 µg (n = 55) | Timolol BID (n = 1) |
||
| Mean BCVA (SD), letters | |||||||||
| Baseline | 82.7 (5.6) | 81.7 (6.4) | 82.2 (6.4) | 84.5 (5.0) | 82.5 (5.8) | 80 | |||
| Month 20 or last visit | 83.3 (5.9) | 81.6 (6.9) | 82.7 (7.0) | 0.662b | 0.193b | 84.7 (6.3) | 81.6 (6.5) | 80 | |
| Patients with > two-line (ten-letter) loss in BCVA from baseline at month 20 or last visit, n (%) | 2 (1.1) | 5 (2.8) | 3 (1.7) | 0.684c | 0.723c | 0 | 2 (3.6) | 0 | |
BCVA best-corrected visual acuity, BID twice daily, Bim bimatoprost implant, SD standard deviation, TEAE treatment-emergent adverse event
aAll patients with a TEAE report of corneal endothelial cell loss, corneal edema, corneal opacity, corneal touch, corneal disorder, or corneal thickening who had a baseline BCVA assessment
bP value based on an analysis of covariance model including treatment with baseline BCVA as the covariate
cP value based on Fisher exact test