Table 5.
Summary of adverse events
| Incidence, n (%) | LT UD (n=105) | AqT UD (n=103) | LT MD (n=51) | AqT MD (n=56) |
|---|---|---|---|---|
| Treatment-emergent AEs | 12 (11.4) | 16 (15.5) | 7 (13.7) | 6 (10.7) |
| Treatment-related AEs | 5 (4.8) | 9 (8.7) | 4 (7.8) | 3 (5.4) |
| Serious AEsa | 1 (1.0) | 0 (0.0) | 0 (0.0) | 1 (1.8) |
| Treatment-emergent AEs reported in ≥2% of subjects in any treatment group | ||||
| Instillation site pain | 4 (3.8) | 4 (3.9) | 2 (3.9) | 2 (3.6) |
| Vision blurred | 3 (2.9) | 4 (3.9) | 2 (3.9) | 2 (3.6) |
| Foreign body sensation in eyes | 1 (1.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
| Visual acuity reduced | 1 (1.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
| Ocular discomfort | 0 (0.0) | 3 (2.9) | 1 (2.0) | 0 (0.0) |
| Eyelid pruritus | 0 (0.0) | 1 (1.0) | 1 (2.0) | 0 (0.0) |
| Conjunctival hemorrhage | 0 (0.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
| Contusion | 0 (0.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
| Madarosis | 0 (0.0) | 0 (0.0) | 1 (2.0) | 0 (0.0) |
Notes:
a
Bile duct stone (LT UD, not treatment-related) and ankle fracture (AqT MD, not treatment-related).
Abbreviations: LT UD, preservative-free unit-dose lipid tear formulation; AqT UD, preservative-free unit-dose aqueous tear formulation; LT MD, preserved multidose lipid tear formulation; AqT MD, preserved multidose aqueous tear formulation; AE, adverse event.