Table 5.
Treatment-related adverse events (incidence ≥1% in either group) from a 3-month clinical trial with a 3-month safety extension
| TRAE | 3 months
|
6 months
|
||||
|---|---|---|---|---|---|---|
| BBFC, n (%)(n=221) | Brinzolamide, n (%) (n=234) | Brimonidine, n (%) (n=235) | BBFC, n (%)(n=221) | Brinzolamide, n (%) (n=234) | Brimonidine, n (%) (n=235) | |
| Ocular | ||||||
| Eye irritation | 12 (5.4) | 4 (1.7) | 6 (2.6) | 14 (6.3) | 3 (1.3) | 8 (3.4) |
| Blurred vision | 10 (4.5) | 16 (6.8) | 0 | 10 (4.5) | 16 (6.8) | 0 |
| Eye allergy | 10 (4.5) | 0 | 2 (0.9) | 14 (6.3) | 1 (0.4) | 5 (2.1) |
| Eye pain | 6 (2.7) | 4 (1.7) | 3 (1.3) | 6 (2.7) | 4 (1.7) | 3 (1.3) |
| Eye pruritus | 5 (2.3) | 3 (1.3) | 0 | 7 (3.2) | 2 (0.9) | 3 (1.3) |
| Allergic conjunctivitis | 4 (1.8) | 1 (0.4) | 5 (2.1) | 8 (3.6) | 1 (0.4) | 10 (4.3) |
| Conjunctival hyperemia | 4 (1.8) | 1 (0.4) | 2 (0.9) | 5 (2.3) | 1 (0.4) | 3 (1.3) |
| Dry eye | 4 (1.8) | 2 (0.9) | 1 (0.4) | 4 (1.8) | 2 (0.9) | 2 (0.9) |
| Conjunctivitis | 4 (1.8) | 0 | 7 (3.0) | 11 (5.0) | 0 | 14 (6.0) |
| Increased lacrimation | 3 (1.4) | 1 (0.4) | 1 (0.4) | 3 (1.4) | 1 (0.4) | 2 (0.9) |
| Ocular hyperemia | 2 (0.9) | 1 (0.4) | 6 (2.6) | 6 (2.7) | 1 (0.4) | 9 (3.8) |
| Conjunctival follicles | 1 (0.5) | 0 | 3 (1.3) | 1 (0.5) | 0 | 4 (1.7) |
| Nonocular | ||||||
| Dysgeusia | 9 (4.1) | 24 (10.3) | 1 (0.4) | 9 (4.1) | 24 (10.3) | 1 (0.4) |
| Dry mouth | 6 (2.7) | 0 | 5 (2.1) | 7 (3.2) | 0 | 5 (2.1) |
| Fatigue | 1 (0.5) | 0 | 4 (1.7) | 1 (0.5) | 0 | 4 (1.7) |
Notes: 3 months data adapted with permission from Nguyen QH, McMenemy MG, Realini T, Whitson JT, Goode SM. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%. J Ocul Pharmacol Ther. 2013;29(3):290–297.54 The publisher for this copyrighted material is Mary Ann Liebert, Inc. publishers. Copyright © 2013. 6 months data is adapted with permission of Dove Medical Press Ltd., from Six-month results from a phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension, Whitson JT, Realini T, Nguyen QH, McMenemy MG, Goode SM, 7, 2013.56 Copyright © 2013.
Abbreviations: BBFC, brinzolamide 1%/brimonidine 0.2% fixed combination; TRAE, treatment-related adverse event.