title: Bimatoprost 0.03%/timolol 0.5% preservative-free ophthalmic solution versus bimatoprost 0.03%/timolol 0.5% ophthalmic solution (Ganfort) for glaucoma or ocular hypertension: a 12-week randomised controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of single-dose bimatoprost 0.03%/timolol 0.5% preservative-free (PF) ophthalmic solution with bimatoprost 0.03%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension.
  
  
  METHODS
  In this multicentre, randomised, parallel-group study, patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for 12 weeks. Primary efficacy endpoints, reflecting differing regional regulatory requirements, included change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12, and the average eye IOP at weeks 2, 6 and 12 in the intent-to-treat population.
  
  
  RESULTS
  561 patients were randomised (278 to bimatoprost/timolol PF; 283 to bimatoprost/timolol); 96.3% completed the study. Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points (p<0.001). Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol. Ocular adverse events were similar between treatment groups, with conjunctival hyperaemia being the most frequent. Most were mild or moderate in severity.
  
  
  CONCLUSIONS
  Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol, with no significant differences in safety and tolerability.
  
  
  BACKGROUND
  NCT01177098.
authors.affiliation: Department of Ophthalmology, University of Sydney, Sydney Eye Hospital, Sydney, Australia.
authors.forename: Ivan
authors.initials: I
authors.lastname: Goldberg
authors.affiliation: Clinica Oftalmologica Rafael Gil Pina, Huelva, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Gil Pina
authors.affiliation: Fundacion Oftalmologica Del Mediterraneo, Valencia, Spain.
authors.forename: Aitor
authors.initials: A
authors.lastname: Lanzagorta-Aresti
authors.affiliation: Allergan, Inc., Irvine, California, USA (at the time the study was conducted).
authors.forename: Rhett M
authors.initials: RM
authors.lastname: Schiffman
authors.affiliation: Allergan, Inc., Irvine, California, USA (at the time the study was conducted).
authors.forename: Charlie
authors.initials: C
authors.lastname: Liu
authors.affiliation: Allergan, Inc., Irvine, California, USA (at the time the study was conducted).
authors.forename: Marina
authors.initials: M
authors.lastname: Bejanian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000577:Amides / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003008:Cloprostenol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / 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*; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects / Q000627:therapeutic use*; D013810:Therapeutic Equivalency; D013999:Timolol / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D014065:Tonometry, Ocular; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D004338:Drug Combinations; C571755:Ganfort; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D003008:Cloprostenol; D013999:Timolol
keywords: Clinical Trial; Drugs; Glaucoma; Treatment Medical