Table 3.
Adverse events
| BRINZ/TIM-FC (n=125) | |
|---|---|
| Total AEs, n (%) | 82 (66) |
| Potential treatment-related AEa, n (%) | 28 (22) |
| Punctate keratitis | 12 (10) |
| Eye irritation | 7 (6) |
| Keratitis | 4 (3) |
| Dysgeusia | 4 (3) |
| Conjunctival hyperemia | 1 (1) |
| Dry eye | 1 (1) |
| Photophobia | 1 (1) |
| Blurred vision | 1 (1) |
| Positional vertigo | 1 (1) |
| Allergic rhinitis | 1 (1) |
| Cough | 1 (1) |
| Discomfort | 1 (1) |
| Malaise | 1 (1) |
| Leukocytopenia | 1 (1) |
| AE incidence according to age in years, n/N (%) | |
| <65 | 36/57 (63) |
| ≥65 | 46/68 (68) |
| AE incidence according to sex, n/n (%) | |
| Men | 38/62 (61) |
| Women | 44/63 (70) |
| AE severity, n (treatment-related/total) | |
| Mild | 26/77 |
| Moderate | 2/13 |
| Severe | 0/2 |
Note:
a
AEs for which a causal relationship with the investigational drug could not be ruled out.
Abbreviations: AE, adverse event; BRINZ/TIM-FC, brinzolamide 1%/timolol 0.5% fixed combination; n/N, number of patients reporting AEs/total group size.