Ocular adverse events reported in ≥2.0% of patients in either group during the 12-week study period (safety population), n (%)
| Adverse event | Bimatoprost/timolol PF (n=278) | Bimatoprost/timolol (n=282) |
|---|---|---|
| Overall* | 92 (33.1) | 95 (33.7) |
| Conjunctival hyperaemia | 59 (21.2) | 55 (19.5) |
| Mild | 46 (16.5) | 44 (15.6) |
| Moderate | 11 (4.0) | 11 (3.9) |
| Severe | 2 (0.7) | 0 (0.0) |
| Eye pruritus | 12 (4.3) | 5 (1.8) |
| Skin hyperpigmentation | 11 (4.0) | 4 (1.4) |
| Dry eye | 9 (3.2) | 3 (1.1) |
| Punctate keratitis | 8 (2.9) | 7 (2.5) |
| Eye pain | 7 (2.5) | 5 (1.8) |
| Foreign body sensation in eyes | 6 (2.2) | 6 (2.1) |
| Eye irritation | 6 (2.2) | 5 (1.8) |
| Growth of eyelashes | 4 (1.4) | 8 (2.8) |
| Erythema of eyelid | 3 (1.1) | 7 (2.5) |
Safety population consisted of all treated patients, and was used for analyses of all safety data based on the actual treatment received. If any patients were misrandomised, the patients were to be analysed as treated.
*Overall incidence of any ocular adverse event.
PF, preservative-free.