Four rabbits were assigned randomly to each dose of Drug A ( 50mg, 25mg, 5mg) or to each dose of Drug B (25mg, 12.5mg, 2.5mg). Draize scores evaluating ocular lesions were assigned at predose, and then at 15 minutes, two hours, and once daily thereafter for six consecutive days, except weekends, following treatment. In addition, two concurrent studies conducted in an essentially identical fashion evaluated 100mg of Drug A and 100mg of Drug B. All data are shown in Table 3.
| Part 6 - Table 3 | |||||||||||||
| Draize Score In Rabbits | |||||||||||||
Minutes |
Days |
||||||||||||
Dose |
Animal |
BS |
15 |
120 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
Drug A |
50mg |
5 |
0 |
6 |
14 |
19 |
2 |
0 |
0 |
WK |
WK |
0 |
|
6 |
0 |
8 |
14 |
14 |
6 |
4 |
2 |
WK |
WK |
0 |
|||
7 |
0 |
8 |
14 |
19 |
15 |
11 |
2 |
WK |
WK |
0 |
|||
8 |
0 |
10 |
14 |
19 |
17 |
17 |
15 |
WK |
WK |
0 |
|||
25mg |
9 |
0 |
10 |
12 |
4 |
9 |
9 |
0 |
WK |
WK |
0 |
||
10 |
0 |
10 |
14 |
21 |
6 |
0 |
0 |
WK |
WK |
0 |
|||
11 |
0 |
8 |
6 |
19 |
4 |
0 |
0 |
WK |
WK |
0 |
|||
12 |
0 |
10 |
14 |
10 |
2 |
0 |
0 |
WK |
WK |
0 |
|||
5mg |
13 |
0 |
6 |
4 |
0 |
0 |
0 |
0 |
WK |
WK |
0 |
||
14 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
WK |
WK |
0 |
|||
15 |
0 |
6 |
4 |
0 |
0 |
0 |
0 |
WK |
WK |
0 |
|||
16 |
0 |
4 |
0 |
0 |
0 |
0 |
0 |
WK |
WK |
0 |
|||
100mg |
1 |
0 |
8 |
16 |
16 |
21 |
17 |
15 |
WK |
WK |
0 |
||
2 |
0 |
8 |
16 |
23 |
15 |
8 |
8 |
WK |
WK |
0 |
|||
3 |
0 |
6 |
16 |
16 |
2 |
0 |
16 |
WK |
WK |
0 |
|||
4 |
0 |
8 |
14 |
21 |
17 |
6 |
0 |
WK |
WK |
0 |
|||
Drug B |
25mg |
21 |
0 |
10 |
12 |
12 |
10 |
6 |
2 |
WK |
WK |
0 |
|
22 |
0 |
10 |
14 |
12 |
12 |
13 |
6 |
WK |
WK |
0 |
|||
23 |
0 |
10 |
12 |
12 |
12 |
4 |
2 |
WK |
WK |
0 |
|||
24 |
0 |
10 |
14 |
14 |
12 |
2 |
0 |
WK |
WK |
0 |
|||
12.5mg |
25 |
0 |
10 |
14 |
12 |
10 |
2 |
0 |
WK |
WK |
0 |
||
26 |
0 |
10 |
12 |
12 |
10 |
0 |
0 |
WK |
WK |
0 |
|||
27 |
0 |
10 |
12 |
12 |
8 |
2 |
0 |
WK |
WK |
0 |
|||
28 |
0 |
10 |
10 |
12 |
4 |
0 |
0 |
WK |
WK |
0 |
|||
2.5mg |
29 |
0 |
4 |
4 |
2 |
0 |
0 |
0 |
WK |
WK |
0 |
||
30 |
0 |
2 |
4 |
2 |
0 |
0 |
0 |
WK |
WK |
0 |
|||
31 |
0 |
4 |
8 |
0 |
0 |
0 |
0 |
WK |
WK |
0 |
|||
32 |
0 |
6 |
8 |
2 |
2 |
0 |
0 |
WK |
WK |
0 |
|||
100mg |
17 |
0 |
10 |
21 |
8 |
8 |
10 |
WK |
WK |
0 |
0 |
||
18 |
0 |
10 |
14 |
12 |
12 |
12 |
WK |
WK |
0 |
0 |
|||
19 |
0 |
10 |
14 |
17 |
13 |
13 |
WK |
WK |
2 |
0 |
|||
20 |
0 |
10 |
14 |
17 |
15 |
12 |
WK |
WK |
2 |
0 |
|||
Bradstreet, T. E. and Short, T. H. (2006) "Favorite Data Sets from Early Phases of Drug Research - Part 6." Proceedings of the Section on Statistical Education of the American Statistical Association.