Table 1.
Demographics of subjects by treatment group (ITT population)
| Demographic | AzaSite Plus™ (N=140) | AzaSite® (N=141) | Dexamethasone (N=136) | Total (N=417) |
|---|---|---|---|---|
| Age (years) | ||||
| Mean (SD) | 59.54 (19.63) | 58.74 (20.11) | 60.63 (18.28) | 59.63 (19.34) |
| Median | 61.5 | 61.0 | 62.5 | 62.0 |
| Min–max | 5.0–90.0 | 7.0–95.0 | 7.0–88.0 | 5.0–95.0 |
| 2–11 years | 4 (2.9%) | 3 (2.1%) | 1 (0.7%) | 8 (1.9%) |
| 12–16 years | 5 (3.6%) | 4 (2.8%) | 2 (1.5%) | 11 (2.6%) |
| 17–64 years | 70 (50.0%) | 73 (51.8%) | 67 (49.3%) | 210 (50.4%) |
| ≥65 years | 61 (43.6%) | 61 (43.3%) | 66 (48.5%) | 188 (45.1%) |
| Pediatric (≤16 years) | 9 (6.4%) | 7 (5.0%) | 3 (2.2%) | 19 (4.6%) |
| Sex | ||||
| Male | 49 (35.0%) | 68 (48.2%) | 58 (42.6%) | 175 (42.0%) |
| Female | 91 (65.0%) | 73 (51.8%) | 78 (57.4%) | 242 (58.0%) |
| Ethnicity | ||||
| Hispanic | 21 (15.0%) | 23 (16.3%) | 21 (15.4%) | 65 (15.6%) |
| Non-Hispanic | 119 (85.0%) | 118 (83.7%) | 115 (84.6%) | 352 (84.4%) |
| Race | ||||
| African American | 8 (5.7%) | 10 (7.1%) | 12 (8.8%) | 30 (7.2%) |
| American Indian | 1 (0.7%) | 1 (0.7%) | 0 (0.0%) | 2 (0.5%) |
| Asian | 3 (2.1%) | 1 (0.7%) | 3 (2.2%) | 7 (1.7%) |
| Caucasian | 119 (85.0%) | 117 (83.0%) | 108 (79.4%) | 344 (82.5%) |
| Other | 9 (6.4%) | 12 (8.5%) | 13 (9.6%) | 34 (8.2%) |
| Iris color | ||||
| Blue | 46 (32.9%) | 46 (32.6%) | 47 (34.6%) | 139 (33.3%) |
| Brown | 61 (43.6%) | 56 (39.7%) | 53 (39.0%) | 170 (40.8%) |
| Green | 8 (5.7%) | 11 (7.8%) | 17 (12.5%) | 36 (8.6%) |
| Hazel | 23 (16.4%) | 27 (19.1%) | 19 (14.0%) | 69 (16.5%) |
| Other | 2 (1.4%) | 1 (0.7%) | 0 (0.0%) | 3 (0.7%) |
Note: AzaSite® and AzaSite Plus™ manufactured by Insite Vision Incorporated, Alameda, CA, USA.
Abbreviations: ITT, intent-to-treat; max, maximum; Min, minimum; SD, standard deviation.