title: Twice-daily brinzolamide/brimonidine fixed combination versus brinzolamide or brimonidine in open-angle glaucoma or ocular hypertension.
abstract: OBJECTIVE
  To compare the intraocular pressure (IOP)-lowering efficacy and safety of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) with that of brinzolamide 1% or brimonidine 0.2% monotherapy, all dosed 2 times per day (BID).
  
  
  METHODS
  Six-month, phase 3, randomized, multicenter, double-masked clinical trial.
  
  
  METHODS
  A total of 560 patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving ≥ 2 IOP-lowering medications.
  
  
  METHODS
  Patients received BBFC (n = 193), brinzolamide 1% (n = 192), or brimonidine 0.2% (n = 175) BID.
  
  
  METHODS
  The primary end point was mean change in diurnal IOP from baseline to month 3. Supportive end points included mean diurnal IOP change from baseline at week 2, week 6, and month 6; and mean IOP, mean IOP change from baseline, mean percentage IOP change from baseline, and percentage of patients with IOP <18 mmHg at week 2, week 6, month 3, and month 6 at each assessment time point (i.e., 9 am, 11 am, and 4 pm). Adverse events were recorded throughout the study.
  
  
  RESULTS
  Baseline diurnal IOP was similar among groups (mean ± standard deviation: BBFC, 25.9 ± 0.19 mmHg; brinzolamide, 25.9 ± 0.20 mmHg; brimonidine, 26.0 ± 0.19 mmHg). At month 3, BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide (least squares [LS] mean difference: -1.4 mmHg; P < 0.0001; t test) and brimonidine (LS mean difference: -1.5 mmHg; P < 0.0001). All supportive end points corroborated the results of the primary efficacy analysis. Mean percentage reductions in IOP from baseline were 26.7% to 36.0% with BBFC, 22.4% to 27.9% with brinzolamide, and 20.6% to 31.3% with brimonidine. The most common adverse drug reactions were ocular side effects, including hyperemia, blurred vision, allergic-type reactions, and discomfort. The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine, whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine.
  
  
  CONCLUSIONS
  Brinzolamide 1% and brimonidine 0.2% fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components.
authors: Singapore National Eye Centre, Singapore; National University of Singapore, Singapore. Electronic address: aung.tin@snec.com.sg.
authors: Tin
authors: T
authors: Aung
authors: Pauls Stradins Clinical University Hospital, Riga, Latvia.
authors: Guna
authors: G
authors: Laganovska
authors: Oftalmica PAHE, Mexico City, Mexico.
authors: Tania Josefina
authors: TJ
authors: Hernandez Paredes
authors: Private Practice, Winston-Salem, North Carolina.
authors: James D
authors: JD
authors: Branch
authors: Szabolcs-Szatmár-Bereg County Hospital, Nyíregyháza, Hungary.
authors: Alexis
authors: A
authors: Tsorbatzoglou
authors: Discipline of Ophthalmology, University of Sydney, Sydney, Australia; Glaucoma Unit, Sydney Eye Hospital, Sydney, Australia; Eye Associates, Sydney, Australia.
authors: Ivan
authors: I
authors: Goldberg
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068438:Brimonidine Tartrate; D002257:Carbonic Anhydrase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; 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*; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000627:therapeutic use; D011810:Quinoxalines / Q000008:administration & dosage / Q000627:therapeutic use*; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D013843:Thiazines / Q000008:administration & dosage / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D002257:Carbonic Anhydrase Inhibitors; D009883:Ophthalmic Solutions; D011810:Quinoxalines; D013449:Sulfonamides; D013843:Thiazines; D000068438:Brimonidine Tartrate; C111827:brinzolamide