May 2008
Volume 49, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2008
Comparison of Safety and Efficacy of Brinzolamide/Timolol (AZARGATM) vs. COSOPT® in Patients With Open-Angle Glaucoma or Ocular Hypertension
Author Affiliations & Notes
  • G. Manni
    Biopatologia e Diagnostica per Immagini, University of Rome Tor Vergata, Rome, Italy
  • P. Denis
    Ophthalmology Department, Hopital Edouard Herriot, Lyon Cedex, France
  • T. Zeyen
    Ophthalmology Department, University St. Rafaël, Leuven, Belgium
  • T. Aung
    Singapore National Eye Centre, Singapore, Singapore
  • I. Filatori
    Alcon Italia spa, Milan, Italy
  • J. James
    Alcon Research, Ltd.,, Fort Worth, Texas
  • C. Salem
    Alcon Research, Ltd.,, Fort Worth, Texas
  • T. Smoot
    Alcon Research, Ltd, Fort Worth, Texas
  • Footnotes
    Commercial Relationships  G. Manni, travel reimbursement, R; P. Denis, travel reimbursement, R; T. Zeyen, travel reimbursement, R; T. Aung, travel reimbursement, R; I. Filatori, Employee of Alcon, E; J. James, Employee of Alcon, E; C. Salem, Employee of Alcon, E; T. Smoot, Employee of Alcon, E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science May 2008, Vol.49, 1211. doi:https://doi.org/
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      G. Manni, P. Denis, T. Zeyen, T. Aung, I. Filatori, J. James, C. Salem, T. Smoot; Comparison of Safety and Efficacy of Brinzolamide/Timolol (AZARGATM) vs. COSOPT® in Patients With Open-Angle Glaucoma or Ocular Hypertension. Invest. Ophthalmol. Vis. Sci. 2008;49(13):1211. doi: https://doi.org/.

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

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Abstract

Purpose: : To compare the intraocular pressure (IOP)-lowering efficacy of Brinzolamide 1%Timolol 0.5% ophthalmic Suspension (Brinz/Tim) and Dorzolamide 2%Timolol 0.5% ophthalmic Solution (COSOPT), each dosed twice-daily in patients with open-angle glaucoma or ocular hypertension in need of additional therapy

Methods: : This was a 12-month multi-center, randomized, double-masked, active controlled parallel group study. Efficacy assessments included mean IOP and mean IOP change from baseline (after wash-out) at 8 AM & 10 AM at Week 2 & Months 3 & 9; and at 8 AM, 10 AM & 4 PM at Months 6 & 12. Primary efficacy was prospectively planned for the Month 6 IOP assessments at 8 AM, 10 AM & 4 PM. Month 9 & 12 were primarily for safety.

Results: : 437 patients were enrolled; 220 were randomized to Brinz/Tim and 217 to COSOPT. Brinz/Tim produced IOP-lowering efficacy that is non-inferior to COSOPT with mean treatment-group differences numerically favoring Brinz/Tim at 9 of 12 assessment times. All upper 95% confidence limits were less than the protocol specified margin of +1.5 mmHg including the Month 6 primary efficacy time points. Brinz/Tim produced mean IOP reductions from baseline that were statistically significant at all measurement times, and ranged from 7 to 9 mmHg with up to 60% of patients achieving IOP levels <18 mmHg. While a similar overall safety profile was observed between the two treatment groups, Brinz/Tim showed an ocular comfort advantage over COSOPT in terms of adverse events for ocular irritation (2.7% vs 10.6%) and ocular pain (2.7% vs 6.5%).

Conclusions: : Brinzolamide 1%/Timolol 0.5% Eye Drops, Suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is non inferior to COSOPT. Additionally, Brinz//Tim provides an ocular comfort advantage over COSOPT.

Clinical Trial: : www.clinicaltrials.gov NCT00314171

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