Intraocular Pressure-Lowering Efficacy of Brinzolamide 1%/Timolol 0.5% Fixed Combination Compared with Brinzolamide 1% and Timolol 0.5%

Autor: Martin, Kaback, Stephen V, Scoper, George, Arzeno, John E, James, Steven Y, Hua, Craig, Salem, Jaime E, Dickerson, Theresa A, Landry, Michael V W, Bergamini, Thomas R, Walters
Rok vydání: 2008
Předmět:
Zdroj: Ophthalmology. 115:1728-1734.e2
ISSN: 0161-6420
DOI: 10.1016/j.ophtha.2008.04.011
Popis: Purpose 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). Design Randomized, double-masked, parallel group, multicenter study. Participants 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. Main Outcome Measure 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%. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
Databáze: OpenAIRE