Table 2.
Adverse events in safety population
| n (%) | PEG eye drops (n=73) | CMC eye drops (n=74) |
|---|---|---|
| Patients experiencing one or more AE | 14 (19) | 22 (30) |
| Treatment-emergent AEs related to eye disorders | ||
| Foreign body sensation in eyes | 3 (4) | 2 (3) |
| Eyelid margin crusting | 2 (3) | 4 (5) |
| Eye pruritus | 2 (3) | 0 |
| Eye allergy | 1 (1) | 0 |
| Eye pain | 1 (1) | 3 (4) |
| Dry eye | 0 | 2 (3) |
| Reduced visual acuity | 0 | 2 (3) |
| Abnormal sensation in eye | 0 | 1 (1) |
| Eye irritation | 0 | 1 (1) |
| Other treatment-emergent AEsa | ||
| Nasopharyngitis | 2 (3) | 3 (4) |
| Upper respiratory tract infection | 2 (3) | 1 (1) |
| Seasonal allergy | 0 | 2 (3) |
| Any serious AE | 1 (1)b | 0 |
| AEs leading to discontinuation | 0 | 3 (4)c |
Notes:
a
Occurring in ≥2% of either group
b
nephrolithiasis, not treatment related
c
two reports of moderate dry eye and one report of moderate eye pain; none were treatment related.
Abbreviations: AE, adverse event; CMC eye drops, carboxymethylcellulose sodium 1% eye drops; PEG eye drops, polyethylene glycol 0.4%, propylene glycol 0.3% eye drops.