Table 3 Treatment-emergent adverse events (TEAEs) and treatment-related ocular TEAEs.
High-Dose Regimen, n (%) (n = 96) | Low-Dose Regimen, n (%) (n = 93) | Vehicle, n (%) (n = 98) | |
|---|---|---|---|
TEAEs* | |||
All TEAEs | 36 (37.5) | 32 (34.4) | 37 (37.8) |
Drug-related TEAEs | 21 (21.9) | 16 (17.2) | 17 (17.3) |
Severity of TEAEs | |||
Mild | 16 (16.7) | 24 (25.8) | 13 (13.3) |
Moderate | 14 (14.6) | 2 (2.2) | 18 (18.4) |
Severe | 6 (6.3) | 6 (6.5) | 6 (6.1) |
Severity of drug-related TEAEs | |||
Mild | 11 (11.5) | 13 (14.0) | 5 (5.1) |
Moderate | 8 (8.3) | 1 (1.1) | 9 (9.2) |
Severe | 2 (2.1) | 2 (2.2) | 3 (3.1) |
Death | 0 | 0 | 0 |
SAE | 2 (2.1) | 1 (1.1) | 0 |
Drug-related SAE | 0 | 0 | 0 |
Discontinuation due to TEAEs | 5 (5.2) | 0 | 10 (10.2) |
Discontinuation due to drug-related TEAEs | 3 (3.1) | 0 | 5 (5.1) |
Treatment-related ocular TEAEs (System Organ Class Preferred Term)** | |||
General disorders & administration site conditions | 13 (13.5) | 16 (17.2) | 6 (6.1) |
Instillation site pain | 9 (9.4) | 7 (7.5) | 4 (4.1) |
Instillation site pruritus | 5 (5.2) | 7 (7.5) | 3 (3.1) |
Instillation site erythema | 0 | 1 (1.1) | 2 (2.0) |
Drug intolerance | 0 | 2 (2.2) | 0 |
Application site discharge | 0 | 0 | 1 (1.0) |
Application site swelling | 0 | 1 (1.1) | 0 |
Eye disorders | 10 (10.4) | 2 (2.2) | 9 (9.2) |
Ocular hyperemia | 3 (3.1) | 2 (2.2) | 1 (1.0) |
Visual acuity reduced | 3 (3.1) | 0 | 2 (2.0) |
Allergic keratitis | 1 (1.0) | 0 | 1 (1.0) |
Ulcerative keratitis | 0 | 0 | 2 (2.0) |
Blepharospasm | 1 (1.0) | 0 | 0 |
Cataract subcapsular | 0 | 0 | 1 (1.0) |
Corneal leukoma | 0 | 0 | 1 (1.0) |
Eye irritation | 1 (1.0) | 0 | 0 |
Eye pain | 1 (1.0) | 0 | 0 |
Eyelid erosion | 1 (1.0) | 0 | 0 |
Eyelid oedema | 0 | 0 | 1 (1.0) |
Investigations | 0 | 0 | 1 (1.0) |
Increased IOP | 0 | 0 | 1 (1.0) |
