Table 6.
Most frequently occurring ocular adverse events
| Preferred terma | Implant dose, N = 239 | ||
|---|---|---|---|
| 0.59-mg, n (%) | 2.1-mg, n (%) | All, n (%) | |
| Study eye | |||
| Intraocular pressure increased | 82 (70.1) | 82 (67.2) | 164 (68.6) |
| Eye pain | 60 (51.3) | 63 (51.6) | 123 (51.5) |
| Visual acuity reduced | 52 (44.4) | 60 (49.2) | 112 (46.9) |
| Conjunctival hemorrhage | 42 (35.9) | 54 (44.3) | 96 (40.2) |
| Postoperative wound complication NOS | 43 (36.8) | 52 (42.6) | 95 (39.8) |
| Conjunctival hyperemia | 49 (41.9) | 41 (33.6) | 90 (37.7) |
| Cataract NOS | 42 (35.9) | 34 (27.9) | 76 (31.8) |
| Cataract NOS aggravated | 37 (31.6) | 39 (32.0) | 76 (31.8) |
| Hypotony of the eye | 29 (24.8) | 47 (38.5) | 76 (31.8) |
| Abnormal sensation in the eye | 31 (26.5) | 35 (28.7) | 66 (27.6) |
| Fellow eye | |||
| Visual acuity reduced | 27 (23.1) | 32 (26.2) | 59 (24.7) |
| Cataract NOS aggravated | 27 (23.1) | 31 (25.4) | 58 (24.3) |
| Eye pain | 24 (20.5) | 29 (23.8) | 53 (22.2) |
| Intraocular pressure increased | 28 (23.9) | 18 (14.8) | 46 (19.3) |
| Cataract NOS | 20 (17.1) | 21 (17.2) | 41 (17.2) |
| Conjunctival hyperemia | 18 (15.4) | 15 (12.3) | 33 (13.8) |
| Vitreous floaters | 11 (9.4) | 22 (18.0) | 33 (13.8) |
| Vision blurred | 14 (12.0) | 16 (13.1) | 30 (12.6) |
| Macular edema | 14 (12.0) | 15 (12.3) | 29 (12.1) |
| Posterior capsule opacification | 11 (9.4) | 14 (11.5) | 25 (10.5) |
NOS not otherwise specified
aMedical dictionary for regulatory activities (MedDRA) preferred nomenclature