Table 7. Adverse events—safety population (N = 59).
| Number (%) of Subjects/Events --- | |||
|---|---|---|---|
| dorzolamide/timolol---- | acetazolamide/dexamethasone---- | Total ---- | |
| Preferred Term | (N = 28) | (N = 31) | (N = 59) |
| Subjects with any Adverse Event | 23 (82.14%) | 30 (96.77%) | 53 (89.83%) |
| Subjects with serious AE | 3 (10.71%) | 4 (12.90%) | 7 (11.86%) |
| Subjects with severe AE | 2 (7.14%) | 12 (38.71%) | 14 (23.73%) |
| Subjects with related AE | 7 (25.00%) | 25 (80.65%) | 32 (54.24%) |
| Subjects with severe related AE | 1 (3.6%) | 9 (29.0%) | 10 (16.95%) |
| Subjects with severe study drug-related AE | 1 (3.57% | 9 (29.03%) | 10 (16.95%) |
| Visual acuity reduced | 15 (53.57%) | 15 (48.39%) | 30 (50.85%) |
| Fatigue | 2 (7.14%) | 13 (41.94%) | 15 (25.42%) |
| Paraesthesia | 0 (0.00%) | 14 (45.16%) | 14 (23.73%) |
| Dysgeusia | 0 (0.00%) | 10 (32.26%) | 10 (16.95%) |
| Conjunctival hyperaemia | 1 (3.57%) | 6 (19.35%) | 9 (4.15%) |
| Dizziness | 2 (7.14%) | 7 (22.58%) | 9 (15.25%) |
| Nausea | 1 (3.57%) | 8 (25.81%) | 9 (15.25%) |
| Eye operation complication | 4 (14.29%) | 5 (16.13%) | 9 (15.25%) |
| Corneal epithelium defect | 0 (0.00%) | 7 (22.58%) | 7 (11.86%) |
| Erythema of eyelid | 4 (14.29%) | 2 (6.45%) | 6 (10.17%) |
| Corneal erosion | 3 (10.71%) | 2 (6.45%) | 5 (8.47%) |
| Headache | 2 (7.14%) | 3 (9.68%) | 5 (8.47%) |
| Abdominal pain upper | 0 (0.00%) | 5 (16.13%) | 5 (8.47%) |
| Epithelial defects grade 3/severe (V3 / V4) | 3 (11.54%); 0 (0.00%) | 1 (3.70%); 1 (3.70%) | 4 (7.55%); 1 (1.92%) |
| Diarrhoea | 0 (0.00%) | 4 (12.90%) | 4 (6.78%) |
| Dyspnoea | 0 (0.00%) | 4 (12.90%) | 4 (6.78%) |
| Eyelid oedema | 1 (3.57%) | 3 (9.68%) | 4 (6.78%) |
| Intraocular pressure increased | 0 (0.00%) | 4 (12.90%) | 4 (6.78%) |
| Palpitations | 0 (0.00%) | 4 (12.90%) | 4 (6.78%) |
| Corneal defect | 1 (3.57%) | 2 (6.45%) | 3 (5.08%) |
| Conjunctival haemorrhage | 2 (7.14%) | 1 (3.23%) | 3 (5.08%) |
| Eye irritation | 2 (7.14%) | 1 (3.23%) | 3 (5.08%) |
| Hypertension | 2 (7.14%) | 1 (3.23%) | 3 (5.08%) |
| Hyphaema | 0 (0.00%) | 3 (9.68%) | 3 (5.08%) |