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

J Glaucoma. 2013 Dec;22(9):707-12. doi: 10.1097/IJG.0b013e318259b47c.


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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Glaucoma, Open-Angle / diagnosis
  • Glaucoma, Open-Angle / drug therapy*
  • Gonioscopy
  • Humans
  • Intraocular Pressure / drug effects
  • Latanoprost
  • Male
  • Middle Aged
  • Ocular Hypertension / diagnosis
  • Ocular Hypertension / drug therapy*
  • Ophthalmic Solutions
  • Prospective Studies
  • Prostaglandins F, Synthetic / adverse effects
  • Prostaglandins F, Synthetic / therapeutic use*
  • Therapeutic Equivalency
  • Tonometry, Ocular


  • Antihypertensive Agents
  • Ophthalmic Solutions
  • Prostaglandins F, Synthetic
  • Latanoprost