Table 5.
Adverse Eventsa (Safety Set)
| Preferred Term | TFNT00 | |||
|---|---|---|---|---|
| First Eye (n = 45) |
Second Eye (n = 44) |
|||
| n (%) | E | n (%) | E | |
| Dry eye | 11 (24) | 11 | 10 (23) | 10 |
| Glare | 10 (22) | 10 | 9 (21) | 9 |
| Visual impairment | 3 (7) | 4 | 3 (7) | 3 |
| Halo vision | 3 (7) | 3 | 3 (7) | 3 |
| Foreign body sensation in eyes | 3 (7) | 3 | 2 (5) | 2 |
| Vitreous floaters | 2 (4) | 2 | 3 (7) | 3 |
| Posterior capsule opacification | 1 (2) | 1 | 2 (5) | 2 |
| Vision blurred | 1 (2) | 1 | 2 (5) | 2 |
| Conjunctivitis allergic | 1 (2) | 1 | 1 (2) | 1 |
| Corneal abrasion | 1 (2) | 1 | 1 (2) | 1 |
| Corneal edema | 1 (2) | 1 | 1 (2) | 1 |
| Meibomian gland dysfunction | 1 (2) | 1 | 1 (2) | 1 |
| Conjunctivitis | 1 (2) | 1 | 0 | 0 |
| Corneal opacity | 1 (2) | 1 | 0 | 0 |
| Device dislocation | 0 | 0 | 1 (2) | 1 |
| Myopia | 0 | 0 | 1 (2) | 1 |
| Optic disc hemorrhage | 1 (2) | 1 | 0 | 0 |
| Photopsia | 1 (2) | 1 | 0 | 0 |
| Surgery | 0 | 0 | 1 (2) | 1 |
AE Adverse event, E Event, n Number of eyes with an event. a If an eye had multiple occurrences of an AE, the eye was presented only once in the respective eye count column for the corresponding AE. Events were counted each time in the event column. AEs were coded using the Medical Dictionary for Regulatory Activities Version 21.0