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Purpose To compare the efficacy and tolerability of the 2% dorzolamide/0.5% timolol combination ophthalmic solution twice daily to the concomitant administration of 0.2% brimonidine ophthalmic solution twice daily and 0.5% timolol ophthalmic solution twice daily. Design Randomized, multicenter, observer-masked, parallel-group study. Participants Two hundred ninety-three patients with ocular hypertension or primary open-angle glaucoma participated. Intervention After an open-label 3-week 0.5% timolol run-in period, patients with an hour 2 intraocular pressure (IOP) of ≥ 22 mmHg were randomly assigned to receive either the dorzolamide/timolol combination twice daily or the concomitant use of brimonidine twice daily and timolol twice daily (brimonidine + timolol) for 6 months. Main outcome measures The IOP-lowering effects at hour 0 and hour 2 were collected at 1, 3, and 6 months. We hypothesized that both treatment regimens would have comparable hour 2 IOP-lowering effects at month 3. The treatments were considered comparable if the two-sided 95% confidence interval of the treatment difference was within ± 1.5 mmHg. Tolerability data were also collected at 1, 3, and 6 months. Results The primary efficacy analysis was based on the modified intent-to-treat population. At month 3, hour 2, the dorzolamide/timolol group had an adjusted mean (standard error) change in IOP of −5.04 (0.30) mmHg versus −5.41 (0.30) mmHg in the brimonidine + timolol group, with a treatment difference of 0.36 (0.40) mmHg (95% confidence interval [CI] of −0.42–1.14 mmHg). At month 3, hour 0, the dorzolamide/timolol group had a change in IOP of −3.66 (0.29) mmHg versus −4.15 (0.28) mmHg in the brimonidine + timolol group, with a treatment difference of 0.49 (0.39) mmHg (95% CI of −0.27–1.25 mmHg). Likewise, at all other observed time points, the 95% confidence interval of the treatment difference was within ± 1.5 mmHg. Ninety-three patients (64%) in the dorzolamide/timolol group and 88 patients (60%) in the brimonidine + timolol group had adverse experiences that were deemed drug related by the investigator, for which 7 patients (5%) in the dorzolamide/timolol group and 8 patients (5%) in the brimonidine + timolol group were discontinued from the study. Conclusions The efficacy of the dorzolamide/timolol combination and the concomitant administration of brimonidine and timolol were comparable. The incidence of drug-related adverse experiences and the incidence of discontinuations caused by drug-related adverse experiences were similar between groups. |
