Table 3.
Safety, local tolerability and compliance in the Safety Set.
| Outcome | Levofloxacin + dexamethasone (N = 395) | Tobramycin + dexamethasone (N = 393) | ||
|---|---|---|---|---|
| No. of patients | No. of patients | |||
| Safety | ||||
| Significant increase vs. baseline of intraocular pressure (>6 mmHg) in the operated eye—no. pts (%) | ||||
| At day 4 | 393 | 5 (1.27) | 393 | 5 (1.27) |
| At day 8 | 391 | 2 (0.51) | 393 | 7 (1.78) |
| At day 15 | 389 | 4 (1.03) | 391 | 2 (0.51) |
| Significant decrease vs. baseline of visual acuity in the operated eye at day 15—no. pts (%)a | 389 | 5 (1.29) | 391 | 11 (2.81) |
| Treatment-emergent adverse events (TEAEs)—no. pts (%) | 395 | 393 | ||
| TEAEs | 56 (14.18) | 51 (12.98) | ||
| Serious TEAEs | 4 (1.01) | 2 (0.51) | ||
| Severe TEAEs | 3 (0.76) | 0 (0.00) | ||
| TEAEs suspected to be related to study treatment | 26 (6.58) | 26 (6.62) | ||
| TEAEs leading to study treatment discontinuation | 4 (1.01) | 3 (0.76) | ||
| Fatal TEAEs | 1 (0.25)b | 0 (0.00) | ||
| Local tolerability | ||||
| Global evaluation: intolerability—no. pts (%)c | ||||
| At day 4 | 393 | 7 (1.78) | 393 | 3 (0.76) |
| At day 8 | 391 | 5 (1.28) | 393 | 8 (2.04) |
| At day 15 | 389 | 6 (1.54) | 391 | 7 (1.79) |
| Burning—no. pts (%)d | ||||
| At day 4 | 393 | 30 (7.63) | 393 | 36 (9.16) |
| At day 8 | 391 | 21 (5.38) | 393 | 41 (10.43) |
| At day 15 | 389 | 26 (6.68) | 391 | 27 (6.91) |
| Stinging—no. pts (%)d | ||||
| At day 4 | 393 | 19 (4.83) | 393 | 17 (4.33) |
| At day 8 | 391 | 22 (5.62) | 393 | 25 (6.36) |
| At day 15 | 389 | 21 (5.39) | 391 | 16 (4.09) |
| Blurred vision—no. pts (%)d | ||||
| At day 4 | 393 | 21 (5.34) | 393 | 16 (4.07) |
| At day 8 | 391 | 22 (5.63) | 393 | 14 (3.56) |
| At day 15 | 389 | 10 (2.57) | 391 | 5 (1.28) |
| Compliance | ||||
| Overall daily dose (drops)—mean ± SDe | 395 | 3.81 ± 0.35 | 393 | 3.87 ± 0.60 |
aBest-corrected visual acuity (BCVA) using ETDRS chart.
bThe death was due to myocardial infarction; the Investigator did not suspect a causal relationship between the event and study treatment.
cGlobal evaluation on a four-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability.
dBurning, stinging, blurred vision on a four-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
eEvaluated through the patient diary, in which the subject is to record all treatments.