Assessing the safety and efficacy of switching to brinzolamide/timolol fixed combination as a replacement therapy in patients with uncontrolled intraocular pressure in Taiwan

PurposeThe objective of this study is to assess the safety and efficacy of switching to brinzolamide 1% and timolol 0.5% fixed combination (BTFC) from prior pharmacotherapy in patients with open-angle glaucoma (OAG) or ocular hypertension (OH) in Taiwan.MethodsThis was a multicenter, open-labeled, interventional prospective study. The 8-week study involved patients with OAG or OH with uncontrolled intraocular pressure (IOP) and consisted of three study visits to the clinical site. Patients were instructed to discontinue their prior medications at the first visit, prior to starting the study medication. Enrolled patients were dosed with BTFC twice daily in both eyes for 8 weeks. IOP measurements and safety evaluations were conducted at both Week 4 and Week 8.ResultsA total of 74 patients were enrolled. The overall mean IOP reductions from baseline after Week 8 of BTFC was 3.45 mmHg (15.42%); when subgrouped by prior medication class (β-blockers vs. non-β-blockers), the reduction in mean IOP after transitioning to BTFC at Week 8 was as follows: subgroup β-blockers were 3.23 mmHg (14.9 %) and non-β-blockers were 3.58 mmHg (15.25%). All mean IOP changes from baseline were statistically significant (p < 0.001). Of the 69 patients (per protocol population) who were switched to BTFC regardless of prior therapy, 37 (53.6%) patients at Week 4 and 38 (55.1%) patients at Week 8 had IOP ≤ 18 mmHg. No treatment-related serious adverse events were reported in this study.ConclusionThe results of this study demonstrated the potential benefit of using BTFC as a replacement therapy in order to ensure adequate IOP control. BTFC administered twice daily was safe and effective in patients with uncontrolled IOP in Taiwan.