An evaluation of therapeutic noninferiority of 0.005% latanoprost ophthalmic solution and xalatan in patients with glaucoma or ocular hypertension

Maurizio Digiuni, Gianluca Manni, Michele Vetrugno, Maurizio Uva, Giovanni Milano, Nicola Orzalesi, Paolo Fogagnolo, Marco Centofanti, Emilio Campos, Luca Rossetti

Research output: Contribution to journalArticlepeer-review

Abstract

PURPOSE:: 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. PATIENTS AND 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.

Original languageEnglish
Pages (from-to)707-712
Number of pages6
JournalJournal of Glaucoma
Volume22
Issue number9
DOIs
Publication statusPublished - Dec 2013

Keywords

  • clinical trial
  • latanoprost
  • medical therapy
  • ocular hypertension
  • primary open-angle glaucoma

ASJC Scopus subject areas

  • Ophthalmology
  • Medicine(all)

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