The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension

J Glaucoma. Apr-May 2009;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.

Abstract

Purpose: This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication.

Methods: This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points.

Results: Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim.

Conclusions: Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adrenergic beta-Antagonists / adverse effects
  • Adrenergic beta-Antagonists / therapeutic use*
  • Adult
  • Aged
  • Aged, 80 and over
  • Carbonic Anhydrase Inhibitors / adverse effects
  • Carbonic Anhydrase Inhibitors / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Glaucoma, Open-Angle / drug therapy*
  • Humans
  • Intraocular Pressure / drug effects*
  • Male
  • Middle Aged
  • Ocular Hypertension / drug therapy
  • Prospective Studies
  • Sulfonamides / adverse effects
  • Sulfonamides / therapeutic use*
  • Thiazines / adverse effects
  • Thiazines / therapeutic use*
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*
  • Timolol / adverse effects
  • Timolol / therapeutic use*
  • Tonometry, Ocular
  • Treatment Outcome
  • Young Adult

Substances

  • Adrenergic beta-Antagonists
  • Carbonic Anhydrase Inhibitors
  • Drug Combinations
  • Sulfonamides
  • Thiazines
  • Thiophenes
  • Timolol
  • brinzolamide
  • dorzolamide