Table 2.
Patient characteristics.
| High-Dose Regimen* (n = 96) | Low-Dose Regimen† (n = 93) | Vehicle (n = 98) | Total (N = 287) | |
|---|---|---|---|---|
| Age‡ | ||||
| Mean, years (SD) | 9.2 (3.4) | 9.1 (3.2) | 8.7 (2.9) | 9.0 (3.2) |
| 4–11 years, n (%) | 73 (76.0) | 71 (76.3) | 79 (80.6) | 223 (77.7) |
| 12–18 years, n (%) | 22 (22.9) | 22 (23.7) | 19 (19.4) | 63 (22.0) |
| Sex, n (%) | ||||
| Male | 78 (81.3) | 75 (80.6) | 75 (76.5) | 228 (79.4) |
| Form of VKC, n (%) | ||||
| Limbal | 8 (8.3) | 2 (2.2) | 7 (7.1) | 17 (5.9) |
| Tarsal | 23 (24.0) | 20 (21.5) | 29 (29.6) | 72 (25.1) |
| Both | 65 (67.7) | 71 (76.3) | 62 (63.3) | 198 (69.0) |
| Type of VKC, n (%) | ||||
| Seasonal | 38 (39.6) | 35 (37.6) | 30 (30.6) | 103 (35.9) |
| Perennial | 58 (60.4) | 58 (62.4) | 68 (69.4) | 184 (64.1) |
| Mean time since diagnosis, years (SD) | 3.8 (2.6) | 3.5 (2.4) | 3.3 (2.4) | 3.5 (2.5) |
| CFS at baseline, n (%) | ||||
| Grade ≤2 | 15 (15.6) | 10 (10.8) | 11 (11.2) | 36 (12.5) |
| Grade 3 | 10 (10.4) | 14 (15.1) | 14 (14.3) | 38 (13.2) |
| Grade 4 | 54 (56.3) | 59 (63.4) | 63 (64.3) | 176 (61.3) |
| Grade 5 | 17 (17.7) | 10 (10.8) | 10 (10.2) | 37 (12.9) |
BID twice daily, CFS corneal fluorescein staining, CsA CE cyclosporine A cationic ophthalmic emulsion, QID 4 times daily, SD standard deviation, VKC vernal keratoconjunctivitis.
*CsA CE 0.1% QID arms from both trials.
†CsA CE 0.05% QID arm from NOVATIVE and CsA CE 0.1% BID data from VEKTIS.
‡Day and month of birth were missing for 1 patient in the NOVATIVE study; they were replaced by the 1st of July for the calculation of age (11 years).