Table 2.
Adverse events (safety population)
| Parameter, n (%) | BAK-free travoprost (n=199) |
|---|---|
| Discontinuations due to AEs | 10 (5.0) |
| Discontinuations due to treatment-related AEsa | |
| Serious AEsb | 4 (2.0) |
| AE severity | |
| Mild | 59 (29.6) |
| Moderate | 13 (6.5) |
| Severe | 1 (0.5)c |
| AEs (incidence ≥2%) | |
| Reduced visual acuity | 5 (2.5) |
| Eye pruritus | 5 (2.5) |
| Ocular hyperemia | 4 (2.0) |
| Headache | 4 (2.0) |
Notes:
a
Eye irritation (n=3), eye pruritus (n=2), eye pain (n=1), photophobia (n=1), blurred vision (n=1), reduced visual acuity (n=1), conjunctivitis (n=1), and foreign body sensation (n=1).
b
Upper gastrointestinal hemorrhage (n=1), cholelithiasis (n=1), and respiratory infection (n=2).
c
Cholelithiasis.
Abbreviations: AEs, adverse events; BAK, benzalkonium chloride.