title: Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial.
abstract: OBJECTIVE
  To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension.
  
  
  METHODS
  In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12.
  
  
  RESULTS
  597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated.
  
  
  CONCLUSIONS
  Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.
authors.affiliation: Coastal Research Associates, Roswell, Georgia 30076, USA. dougday@bellsouth.net
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Day
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Walters
authors.forename: Gail F
authors.initials: GF
authors.lastname: Schwartz
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Mundorf
authors.forename: Charlie
authors.initials: C
authors.lastname: Liu
authors.forename: Rhett M
authors.initials: RM
authors.lastname: Schiffman
authors.forename: Marina
authors.initials: M
authors.lastname: Bejanian
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000577:Amides / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D000069580:Bimatoprost; D003008:Cloprostenol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D005260:Female; D005901:Glaucoma / 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 / Q000008:administration & dosage*; D011446:Prospective Studies; D013810:Therapeutic Equivalency; D014065:Tonometry, Ocular; D014792:Visual Acuity / Q000502:physiology
chemical_list: D000577:Amides; D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D003008:Cloprostenol; D000069580:Bimatoprost
keywords: Glaucoma; Intraocular pressure; Ocular surface; Treatment Medical