title: An evaluation of therapeutic noninferiority of 0.005% latanoprost ophthalmic solution and xalatan in patients with glaucoma or ocular hypertension.
abstract: OBJECTIVE
  To assess the therapeutic noninferiority of 0.005% latanoprost ophthalmic solution versus Xalatan in the treatment of patients with primary open-angle glaucoma or ocular hypertension.
  
  
  METHODS
  This was a double-masked, randomized, multicenter study. A total of 184 patients with a diagnosis of unilateral or bilateral primary open-angle glaucoma or ocular hypertension were randomly assigned to either 0.005% latanoprost ophthalmic solution or Xalatan for 12 weeks. The primary end-point was the change in intraocular pressure (IOP) at 12 weeks in the 2 groups. Noninferiority was reached if the 2-sided 95% confidence intervals (CI) for the difference between adjusted treatment means were entirely within the interval from -1.5 to +1.5 mm Hg.
  
  
  RESULTS
  The difference between treatments in the change of IOP from baseline to the end of treatment was 0.12 mm Hg (95% CI: -0.47, 0.71) in the intention-to-treat population and 0 mm Hg (95% CI: -0.58, 0.57) in the per protocol population. There was no statistically significant difference between the 2 groups in terms of drug-related adverse events. The most commonly reported drug-related local adverse events were: ocular hyperemia, eyelashes growth, and eye irritation.
  
  
  CONCLUSIONS
  This study demonstrates that 0.005% latanoprost ophthalmic solution is noninferior to Xalatan in lowering IOP and is generally well tolerated.
authors.affiliation: *Eye Clinic, San Paolo Hospital, University of Milan, Milan †Eye Clinic, Policlinico Tor Vergata, University of Rome ¶G. B. Bietti Foundation-IRCCS, Rome ‡Eye Clinic, Policlinico University of Bari, Bari §Eye Clinic, Policlinico G. Rodolico, University of Catania, Catania ∥Eye Clinic, Policlinico San Matteo, University of Pavia, Pavia #Eye Clinic, Sant'Orsola Hospital, University of Bologna, Bologna, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Digiuni
authors.forename: Gianluca
authors.initials: G
authors.lastname: Manni
authors.forename: Michele
authors.initials: M
authors.lastname: Vetrugno
authors.forename: Maurizio
authors.initials: M
authors.lastname: Uva
authors.forename: Giovanni
authors.initials: G
authors.lastname: Milano
authors.forename: Nicola
authors.initials: N
authors.lastname: Orzalesi
authors.forename: Paolo
authors.initials: P
authors.lastname: Fogagnolo
authors.forename: Marco
authors.initials: M
authors.lastname: Centofanti
authors.forename: Emilio
authors.initials: E
authors.lastname: Campos
authors.forename: Luca
authors.initials: L
authors.lastname: Rossetti
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005902:Glaucoma, Open-Angle / Q000175:diagnosis / Q000188:drug therapy*; D006068:Gonioscopy; 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; D011446:Prospective Studies; D011461:Prostaglandins F, Synthetic / Q000009:adverse effects / Q000627:therapeutic use*; D013810:Therapeutic Equivalency; D014065:Tonometry, Ocular
chemical_list: D000959:Antihypertensive Agents; D009883:Ophthalmic Solutions; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost