IMPORTANCE: This study evaluates the contribution of the individual components of an investigational non-β-antagonist fixed combination of brinzolamide, 1%, and brimonidine, 0.2%. This study and its sister study provide the first randomized data showing the intraocular pressure (IOP)-lowering activity and the toxicity profile of this novel topical antihypertensive fixed combination. OBJECTIVE: To compare IOP-lowering efficacy of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%, with that of its components in patients with open-angle glaucoma or ocular hypertension. DESIGN: In this phase 3, double-masked, parallel-group, multicenter study, eligible patients were randomized 1:1:1 to treatment with fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%, 3 times daily for 3 months. SETTING: Sixty-six academic and private practice study sites throughout the United States. PARTICIPANTS: A total of 660 adults with a clinical diagnosis of open-angle glaucoma or ocular hypertension from a referred sample were enrolled. Thirty-four patients discontinued participation due to treatment-related nonserious adverse events. INTERVENTION: Topical administration of study medication (fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%) 1 drop 3 times daily for 3 months. MAIN OUTCOMES AND MEASURES: Mean IOP at the 3-month visit at all time points (8 AM, 10 AM, 3 PM, and 5 PM). RESULTS: A total of 660 patients were enrolled. Baseline mean IOP values were similar among treatment groups at all 4 time points. At 3 months, the mean IOP of the brinzolamide-brimonidine group (16.3-19.8 mm Hg) was significantly lower than that of either the brinzolamide group (19.3-20.9 mm Hg; P ≤ .002) or the brimonidine group (17.9-22.5 mm Hg; P < .001) across all time points. One of 10 serious adverse events (chest pain, brinzolamide group) was judged as treatment related. A total of 129 patients experienced at least 1 treatment-related adverse effect (brinzolamide-brimonidine, 22.9%; brinzolamide, 18.6%; and brimonidine, 17.3%; P = .31), most of which were ocular. CONCLUSIONS AND RELEVANCE: This registrational study provides evidence that the fixed combination of brinzolamide, 1%, and brimonidine, 0.2%, can safely and effectively lower IOP in patients with open-angle glaucoma or ocular hypertension, showing significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine monotherapy while providing a safety profile consistent with that of its individual components. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01297517.
RCT Entities:
IMPORTANCE: This study evaluates the contribution of the individual components of an investigational non-β-antagonist fixed combination of brinzolamide, 1%, and brimonidine, 0.2%. This study and its sister study provide the first randomized data showing the intraocular pressure (IOP)-lowering activity and the toxicity profile of this novel topical antihypertensive fixed combination. OBJECTIVE: To compare IOP-lowering efficacy of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%, with that of its components in patients with open-angle glaucoma or ocular hypertension. DESIGN: In this phase 3, double-masked, parallel-group, multicenter study, eligible patients were randomized 1:1:1 to treatment with fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%, 3 times daily for 3 months. SETTING: Sixty-six academic and private practice study sites throughout the United States. PARTICIPANTS: A total of 660 adults with a clinical diagnosis of open-angle glaucoma or ocular hypertension from a referred sample were enrolled. Thirty-four patients discontinued participation due to treatment-related nonserious adverse events. INTERVENTION: Topical administration of study medication (fixed-combination brinzolamide, 1%, and brimonidine, 0.2%; brinzolamide, 1%; or brimonidine, 0.2%) 1 drop 3 times daily for 3 months. MAIN OUTCOMES AND MEASURES: Mean IOP at the 3-month visit at all time points (8 AM, 10 AM, 3 PM, and 5 PM). RESULTS: A total of 660 patients were enrolled. Baseline mean IOP values were similar among treatment groups at all 4 time points. At 3 months, the mean IOP of the brinzolamide-brimonidine group (16.3-19.8 mm Hg) was significantly lower than that of either the brinzolamide group (19.3-20.9 mm Hg; P ≤ .002) or the brimonidine group (17.9-22.5 mm Hg; P < .001) across all time points. One of 10 serious adverse events (chest pain, brinzolamide group) was judged as treatment related. A total of 129 patients experienced at least 1 treatment-related adverse effect (brinzolamide-brimonidine, 22.9%; brinzolamide, 18.6%; and brimonidine, 17.3%; P = .31), most of which were ocular. CONCLUSIONS AND RELEVANCE: This registrational study provides evidence that the fixed combination of brinzolamide, 1%, and brimonidine, 0.2%, can safely and effectively lower IOP in patients with open-angle glaucoma or ocular hypertension, showing significantly superior IOP-lowering activity compared with either brinzolamide or brimonidine monotherapy while providing a safety profile consistent with that of its individual components. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01297517.
Authors: Yoshihiro Inamoto; Igor Petriček; Linda Burns; Saurabh Chhabra; Zachariah DeFilipp; Peiman Hematti; Alicia Rovó; Raquel Schears; Ami Shah; Vaibhav Agrawal; Aisha Ahmed; Ibrahim Ahmed; Asim Ali; Mahmoud Aljurf; Hassan Alkhateeb; Amer Beitinjaneh; Neel Bhatt; Dave Buchbinder; Michael Byrne; Natalie Callander; Kristina Fahnehjelm; Nosha Farhadfar; Robert Peter Gale; Siddhartha Ganguly; Shahrukh Hashmi; Gerhard C Hildebrandt; Erich Horn; Ann Jakubowski; Rammurti T Kamble; Jason Law; Catherine Lee; Sunita Nathan; Olaf Penack; Ravi Pingali; Pinki Prasad; Drazen Pulanic; Seth Rotz; Aditya Shreenivas; Amir Steinberg; Khalid Tabbara; André Tichelli; Baldeep Wirk; Jean Yared; Grzegorz W Basak; Minoo Battiwalla; Rafael Duarte; Bipin N Savani; Mary E D Flowers; Bronwen E Shaw; Nuria Valdés-Sanz Journal: Biol Blood Marrow Transplant Date: 2018-12-03 Impact factor: 5.742
Authors: Stefano A Gandolfi; John Lim; Ana Cristina Sanseau; Juan Camilo Parra Restrepo; Thomas Hamacher Journal: Adv Ther Date: 2014-11-28 Impact factor: 3.845