Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimonidine 0.2%.
J Ocul Pharmacol Ther
; 29(3): 290-7, 2013 Apr.
Article
in En
| MEDLINE
| ID: mdl-23425430
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 ANDMETHODS:
In this phase 3, multicenter, double-masked, parallel-group, 3-month study with a 3-month safety extension, eligible patients were randomized 111 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 800 AM, 1000 AM, 300 PM, and 500 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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quinoxalines
/
Sulfonamides
/
Thiazines
/
Glaucoma, Open-Angle
/
Ocular Hypertension
Type of study:
Clinical_trials
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
J Ocul Pharmacol Ther
Journal subject:
FARMACOLOGIA
/
OFTALMOLOGIA
/
TERAPEUTICA
Year:
2013
Document type:
Article
Affiliation country:
United States