Table 1.
Summary of studies included in pooled analysis of bimatoprost ophthalmic solution 0.03% in glaucoma treatment
| Study number |
Number of patients enrolled in each group |
Study duration, months | Study design | Primary efficacy endpoint | Mean age (range), years | ||
|---|---|---|---|---|---|---|---|
| QD bimatoprost ophthalmic solution 0.03% | BID bimatoprost ophthalmic solution 0.03% | Comparator groups | |||||
| 18,14 | 240 | 240 | 122 | 12 | R, DM, AC, PG | IOP at 8am, 10am, 4pm | 60.7 (22–90) |
| 27,8 | 234 | 243 | 119 | 12 | R, DM, AC, PG | IOP at 8am, 10am, 4pm | 62.4 (26–92) |
| 3a6,9 | 167 | 131 | 81 | 36 | R, DM, AC, PG | IOP reduction from baseline | 62.1 (32–91) |
| 415,16 comparators: timolol 0.5%, exploratory bimatoprost formulation | 129 | – | 391 | 12 | R, DM, AC, PG | IOP at 0, 2, 8 hours | 59.4 (22–91) |
| 515,16 comparators: timolol 0.5%, exploratory bimatoprost formulation | 136 | – | 405 | 12 | R, DM, AC, PG | IOP at 0, 2, 8 hours | 62.4 (24–90) |
| 617 comparators: 2 exploratory bimatoprost formulations | 187 | – | 374 | 12 | R, DM, AC, PG | Mean IOP | 63.5 (23–94) |
Note: Study 3a was a three-year extension of studies 1 and 2; at baseline, all patients had received 12 months of treatment.
Abbreviations: AC, active-controlled; BID, twice daily; DM, double-masked; IOP, intraocular pressure; PG, parallel group; QD, once daily; R, randomized.