Table 2.
Baseline characteristics of the study eye (ITT analysis set)
| Study eye | FE implant (N = 385) | SE implant (N = 380) | Sham/timolol (N = 385) |
p-valuea FE implant vs sham/timolol |
p-valuea SE implant vs sham/timolol |
|---|---|---|---|---|---|
| Diagnosis, n (%) | 0.8445 | 0.3985 | |||
| Open-angle glaucoma | 324 (84.2) | 309 (81.3) | 322 (83.6) | ||
| Ocular hypertension | 61 (15.8) | 71 (18.7) | 63 (16.4) | ||
| Number of IOP-lowering medications used at screening, n (%) | 0.6221 | 0.0992 | |||
| 0 | 114 (29.6) | 126 (33.2) | 100 (26.0) | ||
| 1 | 188 (48.8) | 166 (43.7) | 200 (51.9) | ||
| 2 | 75 (19.5) | 78 (20.5) | 74 (19.2) | ||
| 3b | 8 (2.1) | 10 (2.6) | 11 (2.9) | ||
| Number of IOP-lowering medications used at screening | |||||
| Mean (SD) | 0.9 (0.8) | 0.9 (0.8) | 1.0 (0.8) | ||
| Screening IOP (mmHg) | |||||
| Mean (SD) | 20.24 (4.65) | 20.33 (4.70) | 20.06 (4.45) | 0.5986 | 0.4159 |
| Baseline mean diurnal IOP | |||||
| Mean (SD) | 24.28 (2.99) | 24.05 (2.81) | 24.22 (2.84) | 0.8010 | 0.4080 |
| Baseline mean diurnal IOP category n (%) | 0.9372 | 0.4922 | |||
| ≤ 25 mmHg | 270 (70.1) | 276 (72.6) | 271 (70.4) | ||
| > 25 mmHg | 115 (29.9) | 104 (27.4) | 114 (29.6) | ||
| Baseline IOP at 8AM | |||||
| Mean (SD) | 24.72 (3.70) | 24.46 (3.35) | 24.73 (3.60) | 0.9685 | 0.2843 |
| Iris color, n (%) | 0.4238 | 0.7543 | |||
| Blue | 97 (25.2) | 89 (23.4) | 106 (27.5) | ||
| Brown | 211 (54.8) | 222 (58.4) | 216 (56.1) | ||
| Green | 13 (3.4) | 16 (4.2) | 16 (4.2) | ||
| Hazel | 61 (15.8) | 52 (13.7) | 46 (11.9) | ||
| Other | 3 (0.8) | 1 (0.3) | 1 (0.3) |
FE implant fast-eluting travoprost intracameral implant, IOP intraocular pressure, ITT intent-to-treat, SD standard deviation, SE implant slow-eluting travoprost intracameral implant
ap-value based on two-sample t-test for continuous variables or Pearson chi-squared test for categorical variables
bSubjects with three IOP-lowering medications used at screening were consented under an early protocol version in which subjects were allowed to have up to three IOP-lowering medications