Table 1.
Baseline demographics and study eye characteristics (ITT population)
| Parameter | Bimatoprost implant 10 µg (n = 176) |
Bimatoprost implant 15 µg (n = 176) |
Timolol BID (n = 176) |
P Valuea Bim 10 µg vs. timolol |
P Valuea Bim 15 µg vs. timolol |
|---|---|---|---|---|---|
| Age, mean (SD), years | 62.5 (12.7) | 63.8 (10.7) | 61.4 (12.4) | 0.446 | 0.055 |
| Range | 23–88 | 24–85 | 19–90 | ||
| Gender, n (%) | 0.831 | 0.749 | |||
| Male | 86 (48.9) | 85 (48.3) | 88 (50.0) | ||
| Female | 90 (51.1) | 91 (51.7) | 88 (50.0) | ||
| Race, n (%) | 0.078 | 0.036 | |||
| White | 115 (65.3) | 116 (65.9) | 104 (59.1) | ||
| Hispanic | 22 (12.5) | 27 (15.3) | 21 (11.9) | ||
| Black or AA | 20 (11.4) | 19 (10.8) | 36 (20.5) | ||
| Asian | 11 (6.3) | 6 (3.4) | 13 (7.4) | ||
| Other | 8 (4.5) | 8 (4.5) | 2 (1.1) | ||
| Iris color, n (%) | 0.968 | 0.136 | |||
| Brown | 82 (46.6) | 81 (46.0) | 82 (46.6) | ||
| Dark brown | 30 (17.0) | 16 (9.1) | 31 (17.6) | ||
| Blue | 24 (13.6) | 20 (11.4) | 20 (11.4) | ||
| Hazel | 6 (3.4) | 7 (4.0) | 9 (5.1) | ||
| Green | 5 (2.8) | 2 (1.1) | 2 (1.1) | ||
| Gray | 0 | 4 (2.3) | 1 (0.6) | ||
| Green/brown | 10 (5.7) | 18 (10.2) | 12 (6.8) | ||
| Blue/brown | 14 (8.0) | 20 (11.4) | 14 (8.0) | ||
| Other | 3 (1.7) | 7 (4.0) | 3 (1.7) | ||
| Not reported | 2 (1.1) | 1 (0.6) | 2 (1.1) | ||
| Diagnosis, n (%) | 0.575 | 0.557 | |||
| OAG | |||||
| Primary | 131 (74.4) | 118 (67.0) | 125 (71.0) | ||
| Pigmentary | 3 (1.7) | 7 (4.0) | 4 (2.3) | ||
| Pseudoexfoliation | 1 (0.6) | 2 (1.1) | 2 (1.1) | ||
| OHT | 41 (23.3) | 49 (27.8) | 45 (25.6) | ||
| Lens status | > 0.999 | 0.295 | |||
| Phakic | 135 (76.7) | 143 (81.3) | 135 (76.7) | ||
| Pseudophakic | 41 (23.3) | 33 (18.8) | 41 (23.3) | ||
| CECD, mean (SD), cells/mm2 | 2434.2 (310.8) | 2487.7 (301.9) | 2469.2 (352.4) | 0.324 | 0.598 |
| Range | 1824–3215 | 1811–3719 | 1698–3643 | ||
| IOP, mean (SD), mmHg | |||||
| Hour 0 | 24.3 (2.4) | 24.4 (2.5) | 24.5 (2.5) | 0.500 | 0.790 |
| Hour 2 | 23.2 (2.8) | 23.4 (2.8) | 23.4 (3.1) | 0.533 | 0.943 |
| Diurnal | 23.7 (2.5) | 23.9 (2.4) | 23.9 (2.5) | 0.446 | 0.857 |
AA African American, BID twice daily, Bim bimatoprost implant, CECD central corneal endothelial cell density, IOP intraocular pressure, ITT intent-to-treat, OAG open-angle glaucoma, OHT ocular hypertension, SD standard deviation
aP value based on two-sample t test for continuous variables and chi-square test for categorical values