Table 9. IOP Lowering Data for Simbrinza in OHT/POAG Patientsa (Data Are from the Package Insert for Simbrinza).
Simbrinza | brinzolamide | brimonidine | |||
---|---|---|---|---|---|
mean | mean | difference (95% CI)b | mean | difference (95% CI)b | |
Study 1 | (N = 209) | (N = 224) | (N = 216) | ||
week 2 | |||||
8 AM | 20.4 | 22.0 | –1.6 (−2.3, −0.9) | 22.4 | –2.0 (−2.7, −1.3) |
10 AM | 17.1 | 20.5 | –3.4 (−4.1, −2.7) | 19.4 | –2.3 (−3.0, −1.6) |
3 PM | 18.4 | 20.4 | –1.9 (−2.6, −1.3) | 20.6 | –2.2 (−2.9, −1.5) |
5 PM | 16.6 | 19.7 | –3.2 (−3.9, −2.5) | 18.4 | –1.9 (−2.6, −1.2) |
week 6 | |||||
8 AM | 20.4 | 21.9 | –1.5 (−2.2, −0.8) | 22.6 | –2.3 (−3.0, −1.6) |
10 AM | 17.5 | 20.2 | –2.7 (−3.4, −2.0) | 19.5 | –2.0 {-2.7, −1.3) |
3 PM | 18.9 | 20.2 | –1.2 (−1.9, −0.5) | 21.1 | –2.1 (−2.8, −1.4) |
5 PM | 17.0 | 19.7 | –2.6 (−3.3, −1.9) | 18.6 | –1.5 (−2.2, −0.8) |
month 3 | |||||
8 AM | 20.5 | 21.6 | –1.1 (−1.8, −0.4) | 23.3 | –2.8 (−3.5 −2.1) |
10 AM | 17.2 | 20.4 | –3.2 (−3.9, −2.5) | 19.7 | –2.5 (−3.2, −l.8) |
3 PM | 18.7 | 20.4 | –1.8 (−2.5, −1.1) | 21.3 | –2.6 (−3.3, −1.9) |
5 PM | 17.0 | 20.0 | –3.0 (−3.7, −2.3) | 18.8 | –1.8 (−2.5, −1.1) |
Study 2 | (N = 218) | (N = 229) | (N = 232) | ||
week 2 | |||||
8 AM | 20.5 | 22.2 | -1.7 (−2.4, −1.0) | 22.8 | –2.4 (−3.1, −1.7) |
10 AM | 17.4 | 20.7 | –3.3 (−4.0, −2.6) | 19.2 | -1.8 (−2.5, −1.2) |
3 PM | 18.7 | 20.5 | -1.7 (−2.4, −1.1) | 21.1 | –2.3 (−3.0, −1.6) |
5 PM | 16.5 | 20.1 | –3.6 (−4.3, −2.9) | 18.3 | -1.8 (−2.4, −1.1) |
week 6 | |||||
8 AM | 20.7 | 21.9 | -1.2 (−1.9, −0.5) | 23.2 | –2.5 (−3.2, –l.8) |
10 AM | 17.4 | 20.5 | –3.1 (−3.8, −2.4) | 19.7 | –2.3 (−3.0, −1.6) |
3 PM | 19.3 | 20.2 | –0.8 (−1.5, −0.2) | 21.2 | –1.9 (−2.6, −1.2) |
5 PM | 16.9 | 19.9 | –3.0 (−3.7, −2.3) | 18.5 | –1.7 (−2.4, −1.0) |
month 3 | |||||
8 AM | 21.1 | 22.0 | –1.0 (−1.7, −0.3) | 23.2 | –2.2 (−2.9, −1.5) |
10 AM | 18.0 | 20.8 | –2.8 (−3.5, −2.1) | 19.9 | –1.9 (−2.6, −1.2) |
3 PM | 19.5 | 20.7 | –1.2 (−1.9, −0.5) | 21.5 | –2.0 (−2.7, −1.3) |
5 PM | 17.2 | 20.4 | –3.2 (−3.9, −2.5) | 18.9 | –1.7 (−2.4, −1.0) |
Based on the Intent-to-Treat Population defined as all patients who received study drug and completed at least 1 on-therapy study visit.
The estimates are based on least-squares means derived from a linear mixed model that accounts for correlated IOP measurements within patient; Treatment difference is Simbrinza minus individual component. CI = 95% confidence interval.