title: Efficacy and safety of brinzolamide/timolol fixed combination compared with timolol in Japanese patients with open-angle glaucoma or ocular hypertension.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of brinzolamide 1%/timolol 0.5% fixed-combination (BRINZ/TIM-FC) therapy compared with timolol 0.5% (TIM) monotherapy in Japanese patients with open-angle glaucoma or ocular hypertension.
  
  
  METHODS
  This randomized, double-masked, multicenter study included Japanese patients aged ≥20 years. Patients were treated during a 4-week observation period with TIM monotherapy in advance of randomization to treatment with topical BRINZ/TIM-FC or TIM monotherapy twice daily for 8 weeks. The primary endpoint was mean reduction in intraocular pressure (IOP) from baseline to week 8 at 2 hours postinstillation. Adverse events (AEs) were recorded at each visit.
  
  
  RESULTS
  A total of 301 patients (BRINZ/TIM-FC, n=150; TIM, n=151; age [mean ± standard deviation], 61±13 years) were enrolled. Mean IOP reductions from baseline were greater with BRINZ/TIM-FC than with TIM at weeks 4 and 8 at 0 and 2 hours postinstillation (all P≤0.0001), with mean reductions of -3.2 mmHg with BRINZ/TIM-FC and -1.4 mmHg with TIM at week 8, 2 hours postinstillation. Although AEs were observed in 19% of all patients (BRINZ/TIM-FC, 20%; TIM, 19%), all AEs were mild or moderate.
  
  
  CONCLUSIONS
  BRINZ/TIM-FC therapy was associated with significantly greater reductions in IOP compared with TIM, and it was well tolerated in Japanese patients with open-angle glaucoma or ocular hypertension.
authors.affiliation: Yoshikawa Eye Clinic, Tokyo, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Yoshikawa
authors.affiliation: Kozaki Eye Clinic, Osaka, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Kozaki
authors.affiliation: Maeda Eye Clinic, Osaka, Japan.
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Maeda
keywords: Azarga; beta blocker; carbonic anhydrase inhibitor; intraocular pressure