title: Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial.
abstract: PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, -3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, -4.5 to -2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.
authors.affiliation: Department of Ophthalmology, SUNY Upstate Medical University, Syracuse, NY, USA.
authors.forename: R D
authors.initials: RD
authors.lastname: Fechtner
authors.affiliation: Wills Eye Hospital, Philadelphia, PA, USA.
authors.forename: J S
authors.initials: JS
authors.lastname: Myers
authors.affiliation: Alcon Laboratories, Inc., Fort Worth, TX, USA.
authors.forename: D A
authors.initials: DA
authors.lastname: Hubatsch
authors.affiliation: Department of Ophthalmology, University of North Carolina, Chapel Hill, NC, USA.
authors.forename: D L
authors.initials: DL
authors.lastname: Budenz
authors.affiliation: Clayton Eye Center, Morrow, GA, USA.
authors.forename: H B
authors.initials: HB
authors.lastname: DuBiner
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists; 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; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000175:diagnosis / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic / Q000627:therapeutic use*; D013449:Sulfonamides / Q000627:therapeutic use*; D013843:Thiazines / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D000069557:Travoprost / Q000627:therapeutic use; D014792:Visual Acuity / Q000187:drug effects
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D000959:Antihypertensive Agents; D002257:Carbonic Anhydrase Inhibitors; D004338:Drug Combinations; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D013449:Sulfonamides; D013843:Thiazines; D000068438:Brimonidine Tartrate; D000077338:Latanoprost; C111827:brinzolamide; D000069557:Travoprost