Table 3.
Disposition of enrolled subjects
| Besifloxacin 0.6% | Moxifloxacin 0.5% | Gatifloxacin 0.3% | Total | |
|---|---|---|---|---|
| Randomized (ITT) | 38 (100%) | 38 (100%) | 43 (100%) | 119 (100%) |
| Completed (mITT) | 36 (94.7%) | 36 (94.7%) | 36 (83.7%) | 108 (90.8%) |
| Safety population | 38 (100%) | 36 (94.7%) | 37 (86.0%) | 111 (93.3%) |
| Per-protocol population | 35 (92.1%) | 36 (94.7%) | 35 (81.4%) | 106 (89.1%) |
| Discontinued | 2 (5.3%) | 2 (5.3%) | 7 (16.3%) | 11 (9.2%) |
| Adverse event | 1 (2.6%) | 0 (0.0%) | 2 (4.7%) | 3 (3.5%) |
| Consent withdrawn | 0 (0.0%) | 0 (0.0%) | 2 (4.7%) | 2 (1.7%) |
| Investigator’s decision | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 1 (0.8%) |
| Protocol violation | 1 (2.6%) | 1 (2.6%) | 0 (0.0%) | 2 (1.7%) |
| Administrative reasons | 0 (0.0%) | 0 (0.0%) | 2 (4.7%) | 2 (1.7%) |
| Pregnancya | 0 (0.0%) | 0 (0.0%) | 1 (2.3%) | 1 (0.8%) |
a
Subject had a negative pregnancy test at Visit 1, but reported a positive pregnancy test prior to Visit 2a. The subject was discontinued immediately and did not receive any test medications.
Abbreviations: ITT, intent-to-treat population; mITT, modified intent-to-treat population.