title: Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma.
abstract: OBJECTIVE
  To determine if a test formulation of latanoprost 0.005% (Bausch & Lomb) eyedrops reduced intraocular pressure (IOP) as well as Xalatan® (latanoprost 0.005%) in patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG).
  
  
  METHODS
  This multicenter, randomized, investigator-masked, parallel-group study allocated 266 patients with OH or POAG in a 1:1 ratio to latanoprost or Xalatan administered once daily for 6 weeks. The primary endpoint was the mean change in 8:00 AM IOP of the study eye from baseline to week 6. Secondary endpoints included mean change in 8:00 AM IOP from baseline to week 2, and in 12:00 noon and 4:00 PM IOP from baseline to week 2 and week 6. The safety and tolerability of both drugs were also assessed.
  
  
  RESULTS
  Both study groups had comparable demographics and baseline characteristics. The mean (SD) change in 8:00 AM IOP from baseline to week 6 was -7.29 (2.61) and -7.54 (2.80) mmHg with latanoprost and Xalatan, respectively. Latanoprost was found noninferior to Xalatan in the primary analysis (mean [SEM] treatment difference, 0.252 [0.504] mmHg; 95% confidence interval [CI] -0.408, 0.913; p = 0.0001; noninferiority margin, 1.5 mmHg) and met the predefined definition of equivalence to Xalatan (95% CI within [-1.5, 1.5 mmHg] margin). The IOP-lowering effects of latanoprost and Xalatan were comparable at all assessed time points. Both study treatments demonstrated a comparable safety and tolerability profile.
  
  
  CONCLUSIONS
  Bausch & Lomb latanoprost 0.005% is clinically equivalent to Xalatan for treating OH and POAG as demonstrated through this unique comparative trial.
authors.affiliation: European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry, France. catherine.allaire@bausch.com
authors.forename: Catherine
authors.initials: C
authors.lastname: Allaire
authors.forename: Alice
authors.initials: A
authors.lastname: Dietrich
authors.forename: Helmut
authors.initials: H
authors.lastname: Allmeier
authors.forename: Iveta
authors.initials: I
authors.lastname: Grundmane
authors.forename: Grazyna
authors.initials: G
authors.lastname: Mazur-Piotrowska
authors.forename: Pepo
authors.initials: P
authors.lastname: Neshev
authors.forename: Gunther
authors.initials: G
authors.lastname: Kahle
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure; D005260:Female; D005902:Glaucoma, Open-Angle / Q000188:drug therapy*; D006339:Heart Rate; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects; D013810:Therapeutic Equivalency; D014065:Tonometry, Ocular; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost