Table 3.
Adverse Events Occurring in More Than 3% in the Difluprednate 0.05% Group or in the Prednisolone Acetate 1% Group (Safety Population)*
|
Variable |
Patients,
n
(%) |
|
|
Difluprednate 0.05%, n
= 56 |
Prednisolone Acetate 1%, n
= 54 |
|
| General | ||
| Any AE | 25 (44.6) | 19 (35.2) |
| Any serious AE | 2 (3.6) | 0 |
| AE leading to withdrawal of study medication | 2 (3.6) | 1 (1.9)† |
| Death | 0 | 0 |
| Most common (>3%) AE in any group | ||
| Eye disorder | ||
| Iridocyclitis | 3 (5.4) | 2 (3.7) |
| Punctate keratitis | 3 (5.4) | 0 |
| Uveitis | 2 (3.6) | 1 (1.9) |
| Infections and infestations | ||
| Nasopharyngitis | 2 (3.5) | 1 (1.9) |
| Sinusitis | 2 (3.6) | 0 |
| Investigations | ||
| IOP increased | 5 (8.9) | 2 (3.7) |
| Nervous system disorders | ||
| Headache | 3 (5.4) | 4 (7.4) |
*
An individual reporting more than one event within a preferred term (according to codes used in version 13 of the Medical Dictionary for Regulatory Activities18) was counted only once. Ocular events in an untreated eye were excluded.
†
This patient reported iritis as an AE but discontinued the study because of treatment failure.