Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%.
OBJECTIVE
To compare the safety and intraocular pressure (IOP)-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination with brinzolamide 1% or timolol 0.5% alone in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).


METHODS
Randomized, double-masked, parallel group, multicenter study.


METHODS
Five hundred twenty-three patients were randomized to the study treatments.


METHODS
Patients with OAG or OHT were recruited to the study. Qualifying eyes had IOPs of 24 to 36 mmHg at 8 am and 21 to 36 mmHg at 10 am on 2 eligibility visits after an appropriate washout period from previous treatment. Patients were assigned randomly to either brinzolamide 1%/timolol 0.5%, brinzolamide 1% (Azopt; Alcon Laboratories, Fort Worth, TX), or timolol 0.5%, dosed twice daily and were followed up while receiving therapy for 6 months. At selected sites, additional IOP measurements were performed at 12 pm, 4 pm, and 8 pm during the 2 eligibility visits, at month 3, and at month 6.


METHODS
Mean IOP.


RESULTS
Brinzolamide 1%/timolol 0.5% produced statistically significant and clinically relevant reductions from baseline ranging from 8.0 to 8.7 mmHg, which were statistically and clinically superior to that of either brinzolamide 1% (5.1-5.6 mmHg) or timolol 0.5% (5.7-6.9 mmHg). No safety concerns were identified based on an assessment of ocular and cardiovascular parameters and a review of adverse events.


CONCLUSIONS
Brinzolamide 1%/timolol 05% is superior in IOP-lowering efficacy to either brinzolamide 1% or timolol 0.5%.
Kaback
Martin
M
Glaucoma Consultants of the Capital Region, Slingerlands, New York, USA.
Scoper
Stephen V
SV
Arzeno
George
G
James
John E
JE
Hua
Steven Y
SY
Salem
Craig
C
Dickerson
Jaime E
JE
Landry
Theresa A
TA
Bergamini
Michael V W
MV
D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D011446:Prospective Studies; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D013843:Thiazines / Q000008:administration & dosage* / Q000009:adverse effects; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D014065:Tonometry, Ocular; D014792:Visual Acuity
D000319:Adrenergic beta-Antagonists; D002257:Carbonic Anhydrase Inhibitors; D004338:Drug Combinations; D013449:Sulfonamides; D013843:Thiazines; D013999:Timolol; C111827:brinzolamide