Table 1.
Demographic Data and Baseline Characteristics (Per-Protocol Population*)
|
Variable |
Difluprednate 0.05%, n
= 46 |
Prednisolone Acetate 1%, n
= 47 |
Overall, N
= 93 |
| Age, y | |||
| Mean (SD) | 49.9 (15.3) | 46.2 (17.7) | 48.0 (16.6) |
| Minimum, maximum | 11, 87 | 12, 76 | 11, 87 |
| Age group, y, n (%) | |||
| 2–11 | 1 (2.2) | 0 | 1 (1.1) |
| 12–17 | 1 (2.2) | 1 (2.1) | 2 (2.2) |
| 18–64 | 39 (84.8) | 35 (74.5) | 74 (79.6) |
| ≥65 | 5 (10.9) | 11 (23.4) | 16 (17.2) |
| Race, n (%) | |||
| White | 28 (60.9) | 25 (53.2) | 53 (57.0) |
| Black | 15 (32.6) | 19 (40.4) | 34 (36.6) |
| Other | 3 (6.5) | 3 (6.4) | 6 (6.5) |
| Sex, n (%) | |||
| Female | 24 (52.2) | 27 (57.4) | 51 (54.8) |
| Treatment duration, d* | |||
| Mean (SD) | 27.0 (7.1) | 28.7 (8.3) | NA |
| Anterior chamber cell grade | |||
| Mean (SD) | 2.6 (0.7) | 2.6 (0.7) | NA |
| Anterior chamber flare grade | |||
| Mean (SD) | 2.2 (0.5) | 2.3 (0.5) | NA |
| VAS total score† | |||
| Mean (SD) | 186.7 (112.6) | 203.2 (110.8) | NA |
| BCVA, logMAR equivalent* | |||
| Mean (SD) | 0.22 (0.29) | 0.32 (0.40) | NA |
| OCT center thickness, μm | |||
| Mean (SD) | 199.8 (38.0) | 201.5 (38.9) | NA |
NA, not applicable.
*
Safety population was used for treatment duration and baseline BCVA for difluprednate 0.05% (n = 56) and prednisolone acetate 1% (n = 54).
†
Difluprednate 0.05% (n = 44) and prednisolone acetate 1% (n = 46). The total VAS symptom score was calculated as the sum of four symptom scores (eye pain, photophobia, blurred vision, and lacrimation). Each symptom score was graded by the patient according to a VAS (range, 0–100) using a mark on a 100-mm line (range, 0 for absent to 100 for maximal).