title: A Randomized Trial of Fixed-Dose Combination Brinzolamide 1%/Brimonidine 0.2% as Adjunctive Therapy to Travoprost 0.004.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension.
  
  
  METHODS
  Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial.
  
  
  METHODS
  setting: Multicenter; 32 sites in the United States.
  
  
  METHODS
  Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) ≥21 mm Hg and <32 mm Hg while receiving once-daily TRAV monotherapy.
  
  
  METHODS
  Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks.
  
  
  METHODS
  Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC+TRAV over vehicle+TRAV was based on statistical significance of a treatment difference favoring BBFC+TRAV.
  
  
  RESULTS
  Mean diurnal IOP at week 6 (least squares mean ± standard error) was 17.6 ± 0.4 mm Hg and 20.7 ± 0.4 mm Hg in the BBFC+TRAV and vehicle+TRAV groups, respectively (between-group difference, -3.2 ± 0.5 mm Hg; P < .0001). Superiority of BBFC+TRAV over vehicle+TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC+TRAV compared with vehicle+TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC+TRAV, 12.8%; vehicle+TRAV, 6.0%).
  
  
  CONCLUSIONS
  Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.
authors.affiliation: Robert Cizik Eye Clinic, Ruiz Department of Ophthalmology and Visual Sciences, McGovern Medical School at The University of Texas Health Science Center (UTHealth), Houston, Texas. Electronic address: robert.m.feldman@uth.tmc.edu.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Feldman
authors.affiliation: Department of Ophthalmology, St. Joseph Mercy Medical Center, Ann Arbor, Michigan.
authors.forename: Gregory
authors.initials: G
authors.lastname: Katz
authors.affiliation: Lone Star Eye Care, PA, Sugar Land, Texas.
authors.forename: Matthew
authors.initials: M
authors.lastname: McMenemy
authors.affiliation: Alcon Laboratories, Inc, Fort Worth, Texas.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Hubatsch
authors.affiliation: Department of Ophthalmology, West Virginia University, Morgantown, West Virginia.
authors.forename: Tony
authors.initials: T
authors.lastname: Realini
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D000068438:Brimonidine Tartrate / Q000627:therapeutic use*; D002257:Carbonic Anhydrase Inhibitors / Q000627:therapeutic use; 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 / Q000627:therapeutic use*; D013843:Thiazines / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D000069557:Travoprost / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D000959:Antihypertensive Agents; D002257:Carbonic Anhydrase Inhibitors; D004338:Drug Combinations; D013449:Sulfonamides; D013843:Thiazines; D000068438:Brimonidine Tartrate; C111827:brinzolamide; D000069557:Travoprost