Table 1.
Demographic and clinical characteristics (mITT population)
| Variable | Test 1 (n=88) | Test 2 (n=75) | Control (n=93) |
| Integer age* | |||
| Mean, years (SD) | 8.0 (1.2) | 8.2 (1.2) | 8.2 (1.2) |
| Age group, n (%) | |||
| 6 years | 10 (11.4) | 8 (10.7) | 9 (9.7) |
| 7 years | 20 (22.7) | 13 (17.3) | 18 (19.4) |
| 8 years | 23 (26.1) | 17 (22.7) | 24 (25.8) |
| 9 years | 27 (30.7) | 28 (37.3) | 32 (34.4) |
| 10 years | 8 (9.1) | 9 (12.0) | 10 (10.8) |
| Sex, (n (%)) | |||
| Male | 39 (44.3) | 29 (38.7) | 39 (41.9) |
| Female | 49 (55.7) | 46 (61.3) | 54 (58.1) |
| Ethnicity, (n (%)) | |||
| Hispanic or Latino | 18 (20.5) | 10 (13.3) | 17 (18.3) |
| Not Hispanic or Latino | 70 (79.5) | 65 (86.7) | 76 (81.7) |
| Race† | |||
| White | 64 (72.7) | 55 (73.3) | 71 (76.3) |
| Black or African American | 19 (21.6) | 13 (17.3) | 17 (18.3) |
| American Indian or Alaska Native | 2 (2.3) | 1 (1.3) | 2 (2.2) |
| Asian Indian | 1 (1.1) | 5 (6.7) | 2 (2.2) |
| Chinese | 2 (2.3) | 2 (2.7) | 3 (3.2) |
| Filipino | 0 (0) | 1 (1.3) | 0 (0) |
| Japanese | 0 (0) | 1 (1.3) | 1 (1.1) |
| Other Asian | 2 (2.3) | 2 (2.7) | 3 (3.2) |
| Native Hawaiian or Other Pacific Islander | 1 (1.1) | 0 (0) | 0 (0) |
| Myopic parents‡, n (%) | |||
| Two | 29 (33.0) | 36 (48.0) | 34 (36.6) |
| At least one | 7 (8.0) | 8 (10.7) | 10 (10.8) |
| One | 36 (40.9) | 22 (29.3) | 42 (45.2) |
| Zero | 9 (10.2) | 8 (10.7) | 7 (7.5) |
| Unknown | 7 (8.0) | 1 (1.3) | 0 (0) |
| Axial Length, mm (mean (SD), range) | 24.09 (0.82) 22.03 to 26.25 |
23.94 (0.70) 22.33 to 25.42 |
24.03 (0.78) 22.13 to 25.72 |
| Cycloplegic SER, D (mean (SD), range)§ | −2.00 (0.93) −4.52 to −0.19 |
−1.85 (0.91) −4.60 to −0.50 |
−1.95 (1.02) −4.94 to −0.38 |
*Integer age is the subject’s age rounded down to the nearest whole year.
†Proportion may not sum to 100% as subjects selecting more than one race will be counted multiple times.
‡Subjects/parents were given the options: unknown, zero, one, at least one or two.
§Subjects were screened based on manifest refraction and were required have at least −0.75 D SER, however, in a small number of cases the cycloplegic SER revealed less myopia.
mITT, modified intent to treat; SER, spherical equivalent refractive error.