Table 1.
Demographics and baseline characteristics (full analysis set).
| Characteristics | BBFC + PGA N = 95 |
Vehicle + PGA N = 92 |
|---|---|---|
| Age, years (mean (±SD)) | 66.5 (10.70) | 67.9 (11.65) |
| Gender, female, n (%) | 55 (57.9) | 43 (46.7) |
| Race, n (%) | ||
| White | 87 (91.6) | 85 (92.4) |
| Black or African American | 5 (5.3) | 7 (7.6) |
| Asian | 3 (3.2) | 0 (0.0) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 23 (24.2) | 29 (31.5) |
| Not Hispanic or Latino | 72 (75.8) | 62 (67.4) |
| Unknown | 0 (0.0) | 1 (1.1) |
| Baseline diurnal IOP (mean (±SD), mm Hg) | 22.8 (2.39) | 22.9 (2.32) |
| Baseline IOP category, n (%) | ||
| 19–26 mm Hg | 89 (93.7) | 84 (91.3) |
| 27–32 mm Hg | 6 (6.3) | 7 (7.6) |
| PGA monotherapy, n (%) | ||
| Bimatoprost 0.01% | 32 (33.7) | 30 (32.6) |
| Latanoprost 0.005% | 38 (40.0) | 37 (40.2) |
| Travoprost 0.004% | 25 (26.3) | 25 (27.2) |
| Corneal thickness (mean (± SD) μm) | 539.1 (34.43) | 545.5 (33.73) |
| Corneal thickness categories | ||
| ⩽0.55 μm | 57 (60.0) | 45 (48.9) |
| >0.55–0.60 μm | 35 (36.8) | 43 (46.7) |
| >0.60 μm | 3 (3.2) | 4 (4.3) |
| Diagnosis, n (%) | ||
| Open-angle glaucoma | 78 (82.1) | 74 (80.4) |
| Ocular hypertension | 17 (17.9) | 17 (18.5) |
BBFC: brinzolamide 1%/brimonidine 0.2% fixed-dose combination; N: total number of patients; PGA: prostaglandin analog; SD: standard deviation; n: number of patients; IOP: intraocular pressure.
One patient with an IOP level < 19 mm Hg was randomized in error from the site and received treatment. This patient was included in the full analysis set. Baseline IOP is expressed as mean (SD) and defined as the average of 09:00 a.m. and 11:00 a.m. values.