April 2014
Volume 55, Issue 13
ARVO Annual Meeting Abstract  |   April 2014
Efficacy and Tolerability of Switching to Brinzolamide/Timolol Fixed Combination From Brimonidine/Timolol Fixed Combination in Latin America
Author Affiliations & Notes
  • Arturo A. Alezzandrini
    University of Buenos Aires, Buenos Aires, Argentina
  • Douglas A Hubatsch
    Alcon Laboratories, Inc., Fort Worth, TX
  • Rene Alfaro
    Colegio Mexicano de Oftalmologia and Sociedad Mexicana de Oftalmologia, San Miguel Chapultepec, Mexico
  • Footnotes
    Commercial Relationships Arturo Alezzandrini, None; Douglas Hubatsch, Alcon Laboratories, Inc. (E); Rene Alfaro, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 557. doi:
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      Arturo A. Alezzandrini, Douglas A Hubatsch, Rene Alfaro; Efficacy and Tolerability of Switching to Brinzolamide/Timolol Fixed Combination From Brimonidine/Timolol Fixed Combination in Latin America. Invest. Ophthalmol. Vis. Sci. 2014;55(13):557.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: To assess the efficacy and tolerability of twice-daily fixed-combination brinzolamide 1%/timolol 0.5% (BRINZ/TIM-FC; AZARGA®, Alcon Laboratories, Fort Worth, TX, USA) in patients with open-angle glaucoma or ocular hypertension in Latin America previously on brimonidine 0.2%/timolol 0.5% (BRIM/TIM-FC; COMBIGAN®, Allergan, Inc., Irvine, CA, USA) fixed-combination therapy

Methods: This 8-week, open-label, prospective study was conducted at 6 sites in Argentina, Chile, and Mexico and enrolled patients ≥18 years with primary, exfoliative, or pigment-dispersion open-angle glaucoma or ocular hypertension who had intraocular pressure (IOP) ranging from 19−35 mmHg in ≥1 eye at baseline (on BRIM/TIM-FC). Patients instilled 1 drop of BRINZ/TIM-FC in the study eye twice daily, at 8 AM and 8 PM, for 8 weeks. The primary efficacy endpoint was the mean change in IOP from baseline to week 8, and the secondary efficacy endpoint was the percentage of patients reaching target IOP (≤18 mmHg) at week 8. Exploratory endpoints included patient and investigator preference for treatment assessed using a global preference response questionnaire at week 8. Safety assessments included adverse events (AEs). IOP change was analyzed using Wilcoxon signed rank tests.

Results: In total, 50 patients (mean age, 67±12 years) received BRINZ/TIM-FC and were included in the intent-to-treat population. A significant reduction in mean ± SD IOP from baseline was observed after 8 weeks of treatment with BRINZ/TIM-FC (−3.60±3.01 mmHg; P<0.0001); the mean percentage reduction in IOP from baseline to week 8 was 17.1%. Overall, 55.3% of patients reached the target IOP of ≤18 mmHg. Significantly more patients (89.4%) and investigators (95.7%) preferred BRINZ/TIM-FC to BRIM/TIM-FC (both P<0.0001; exact binomial test). Thirteen AEs were observed, of which 8 were related to BRINZ/TIM-FC; the most common treatment-related AEs were eye irritation (n=4) and abnormal sensation in the eye (n=2).

Conclusions: BRINZ/TIM-FC significantly reduced IOP when used as replacement treatment in patients previously treated with BRIM/TIM-FC and was preferred to BRIM/TIM-FC. The safety profile of BRINZ/TIM-FC was comparable with previously reported studies; no AEs were identified other than those already associated with topical β-blockers and carbonic anhydrase inhibitors.

Keywords: 443 carbonic anhydrase • 568 intraocular pressure • 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials  

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