Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%.

Abstract

PURPOSE:

This study compared the intraocular pressure (IOP)-lowering efficacy of fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) with that of its component medications, brinzolamide and brimonidine, in patients with open-angle glaucoma or ocular hypertension.

PATIENTS AND METHODS:

In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 1:1:1 to treatment with BBFC, brinzolamide, or brimonidine thrice daily after a washout period, during which any IOP-lowering medications were discontinued. The primary objectives of this study were to determine whether the IOP-lowering efficacy of BBFC was superior to that of brinzolamide alone and, separately, of brimonidine alone. IOP was assessed at 8:00 AM, 10:00 AM, 3:00 PM, and 5:00 PM at 2 weeks, 6 weeks, and 3 months after study drug initiation.

RESULTS:

A total of 690 patients were enrolled in the study, and 615 completed the 3-month visit. Baseline mean IOP levels were similar among the 3 treatment groups at each of the 4 time points assessed. At the 3-month primary endpoint, mean IOP of the BBFC group was significantly lower than that of either the brinzolamide group or the brimonidine group (P≤0.005) across all time points. At the 2- and 6-week supportive endpoints, mean IOP of the BBFC group was significantly lower at all time points than the mean IOP of either the brinzolamide group (P≤0.01) or the brimonidine group (P<0.0001). A total of 143 patients experienced at least 1 treatment-related adverse event (AE; BBFC group, n=58, 26.2%; brinzolamide group, n=44, 18.8%; brimonidine group, n=41, 17.4%), the majority of which were ocular AEs.

CONCLUSIONS:

This study demonstrated that BBFC has significantly superior IOP-lowering activity compared with either brinzolamide 1% or brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension while providing a safety profile which is consistent with that of the individual components.

• Authors: Quang H Nguyen, Matthew G McMenemy, Tony Realini, Jess T Whitson, Stephen M Goode
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 29 Issue 3 Pg. 290-7 (Apr 2013) ISSN: 1557-7732 [Electronic] United States
• PMID: 23425430 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adrenergic alpha-2 Receptor Agonists
• Carbonic Anhydrase Inhibitors
• Drug Combinations
• Quinoxalines
• Sulfonamides
• Thiazines
• Brimonidine Tartrate
• brinzolamide

Topics

• Administration, Ophthalmic
• Adrenergic alpha-2 Receptor Agonists (administration & dosage, adverse effects, therapeutic use)
• Aged
• Brimonidine Tartrate
• Carbonic Anhydrase Inhibitors (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Female
• Glaucoma, Open-Angle (drug therapy, pathology)
• Humans
• Intraocular Pressure (drug effects)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy, pathology)
• Quinoxalines (administration & dosage, adverse effects, therapeutic use)
• Sulfonamides (administration & dosage, adverse effects, therapeutic use)
• Thiazines (administration & dosage, adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome