Table 3.
Treatment-emergent ocular adverse events in study eyes by time of onset after bimatoprost implant or sham procedure administration
| TEAE | Onset within 2 days, n (%) | Onset after 2 days, n (%) | ||||
|---|---|---|---|---|---|---|
| Bimatoprost implant 10 µg (n = 175) |
Bimatoprost implant 15 µg (n = 176) |
Timolol BID (n = 173) |
Bimatoprost implant 10 µg (n = 175) |
Bimatoprost implant 15 µg (n = 176) |
Timolol BID (n = 173) |
|
| Conjunctival hyperemia | 36 (20.6) | 56 (31.8) | 16 (9.2) | 23 (13.1) | 39 (22.2) | 5 (2.9) |
| Conjunctival hemorrhage | 16 (9.1) | 12 (6.8) | 11 (6.4) | 0 | 2 (1.1) | 3 (1.7) |
| Foreign body sensation in eye | 13 (7.4) | 14 (8.0) | 2 (1.2) | 7 (4.0) | 5 (2.8) | 0 |
| Eye pain | 11 (6.3) | 15 (8.5) | 5 (2.9) | 0 | 11 (6.3) | 3 (1.7) |
| Photophobia | 11 (6.3) | 12 (6.8) | 0 | 2 (1.1) | 3 (1.7) | 0 |
| Eye irritation | 7 (4.0) | 7 (4.0) | 3 (1.7) | 3 (1.7) | 5 (2.8) | 4 (2.3) |
| Aqueous humor leakage | 5 (2.9) | 1 (0.6) | 0 | 0 | 0 | 0 |
| Punctate keratitis | 5 (2.9) | 8 (4.5) | 2 (1.2) | 3 (1.7) | 6 (3.4) | 5 (2.9) |
| Anterior chamber cell | 4 (2.3) | 6 (3.4) | 1 (0.6) | 4 (2.3) | 6 (3.4) | 0 |
| Dry eye | 4 (2.3) | 9 (5.1) | 4 (2.3) | 8 (4.6) | 9 (5.1) | 3 (1.7) |
| Lacrimation increased | 4 (2.3) | 5 (2.8) | 1 (0.6) | 2 (1.1) | 5 (2.8) | 0 |
| Vision blurred | 4 (2.3) | 4 (2.3) | 0 | 5 (2.9) | 3 (1.7) | 1 (0.6) |
| Ocular discomfort | 3 (1.7) | 7 (4.0) | 1 (0.6) | 0 | 5 (2.8) | 0 |
| Iritis | 2 (1.1) | 3 (1.7) | 0 | 7 (4.0) | 6 (3.4) | 0 |
| Blepharitis | 1 (0.6) | 2 (1.1) | 0 | 8 (4.6) | 5 (2.8) | 5 (2.9) |
| Vitreous detachment | 1 (0.6) | 0 | 0 | 2 (1.1) | 4 (2.3) | 1 (0.6) |
| Conjunctivitis allergic | 0 | 1 (0.6) | 0 | 5 (2.9) | 2 (1.1) | 2 (1.2) |
| Corneal edema | 0 | 2 (1.1) | 0 | 6 (3.4) | 21 (11.9) | 0 |
| Corneal endothelial cell loss | 0 | 0 | 0 | 14 (8.0) | 45 (25.6) | 1 (0.6) |
| Corneal touch | 0 | 0 | 0 | 2 (1.1) | 4 (2.3) | 0 |
| Erythema of eyelid | 0 | 1 (0.6) | 1 (0.6) | 4 (2.3) | 2 (1.1) | 0 |
| Intraocular pressure increased | 0 | 2 (1.1) | 1 (0.6) | 14 (8.0) | 15 (8.5) | 5 (2.9) |
| Iris adhesions | 0 | 0 | 0 | 4 (2.3) | 3 (1.7) | 0 |
| Iris hyperpigmentation | 0 | 0 | 0 | 5 (2.9) | 5 (2.8) | 0 |
| Vitreous floaters | 0 | 0 | 0 | 5 (2.9) | 1 (0.6) | 2 (1.2) |
| Overalla | 77 (44.0) | 95 (54.0) | 42 (24.3) | 84 (48.0) | 119 (67.6) | 60 (34.7) |
| P valueb | < 0.001 | < 0.001 | – | 0.012 | < 0.001 | – |
BID twice daily, TEAE treatment-emergent adverse event. All ocular TEAEs in study eyes that were reported in ≥ 2% of subjects in any treatment group within 2 days or after 2 days following administration are listed
aAny ocular TEAE in the study eye
bP value for comparison of overall TEAE vs. timolol (chi-square test)