Maximum hyperaemia score according to dosing sequences
| Ocular hyperaemia | Sequence 01:00 (n=6) | Sequence 02:00 (n=6) | Sequence 13:00 (n=6) | Sequence 14:00 (n=6) | Pooled AM (n=12) | Pooled PM (n=12) | |
|---|---|---|---|---|---|---|---|
| Study day/period | Grade | n/N (%) | n/N (%) | n/N (%) | n/N (%) | n/N (%) | n/N (%) |
| Post first dose through follow-up | 0 | 0/6 (0.0) | 1/6 (16.7) | 0/6 (0.0) | 0/6 (0.0) | 1/12 (8.3) | 0/12 (0.0) |
| 0.5 | 0/6 (0.0) | 4/6 (66.7) | 1/6 (16.7) | 0/6 (0.0) | 4/12 (33.3) | 1/12 (8.3) | |
| 1 | 5/6 (83.3) | 0/6 (0.0) | 5/6 (83.3) | 4/6 (66.7) | 5/12 (41.7) | 9/12 (75.0) | |
| 1.5 | 0/6 (0.0) | 0/6 (0.0) | 0/6 (0.0) | 0/6 (0.0) | 0/12 (0.0) | 0/12 (0.0) | |
| 2 | 1/6 (16.7) | 1/6 (16.7) | 0/6 (0.0) | 1/6 (16.7) | 2/12 (16.7) | 1/12 (8.3) | |
| 2.5 | 0/6 (0.0) | 0/6 (0.0) | 0/6 (0.0) | 0/6 (0.0) | 0/12 (0.0) | 0/12 (0.0) | |
| 3 | 0/6 (0.0) | 0/6 (0.0) | 0/6 (0.0) | 1/6 (16.7) | 0/12 (0.0) | 1/12 (8.3) | |
Sequence 1, (AM→PM); sequence 2, (PM→AM); AM, once daily morning; PM, once daily evening.
Score interpretation: ≥0 or 0.5, no hyperaemia; 1 or 1.5, mild hyperaemia; 2 or 2.5, moderate hyperaemia; 3, severe hyperaemia; when two eyes in the same subject had different results, the worse (more severe grade) score was used.