Randomized clinical trial of latanoprost and unoprostone in patients with elevated intraocular pressure

Am J Ophthalmol. 2002 Dec;134(6):863-71. doi: 10.1016/s0002-9394(02)01820-2.

Abstract

Purpose: To compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost 0.005% once daily with that of unoprostone 0.15% twice daily for patients with primary open-angle glaucoma or ocular hypertension.

Design: Randomized clinical trial.

Methods: In a prospective, 8-week, investigator-masked, parallel-group study conducted at numerous centers in the United States, 165 previously treated patients with IOP >or= 25 mm Hg in one or both eyes after washout were randomly assigned to receive either latanoprost 0.005% once daily in the evening or unoprostone 0.15% twice daily. Observations procedures were Goldmann applanation tonometry, best-corrected visual acuity, slit lamp biomicroscopy, and ophthalmoscopy. The main outcome measure was change in the mean of the IOPs measured at 8:00 AM, 12 noon, and 4:00 PM between baseline (before treatment) and after 8 weeks of treatment.

Results: The change in the mean +/- SD of the IOPs measured at 8:00 AM, 12 noon, and 4:00 PM was -7.2 +/- 3.2 mm Hg (28%) for latanoprost (25.3 +/- 2.8 mm Hg at baseline to 18.2 +/- 2.8 mm Hg at 8 weeks) and -3.9 +/- 2.6 mm Hg (15%) for unoprostone (25.5 +/- 3.3 mm Hg at baseline to 21.6 +/- 4.0 mm Hg; P <or=.001. No serious adverse event related to either medication was reported.

Conclusions: Over an 8-week period, latanoprost 0.005% once daily lowered IOP more than unoprostone 0.15% twice daily in patients with elevated IOP. Both agents were safe and well tolerated.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / therapeutic use*
  • Dinoprost / administration & dosage
  • Dinoprost / analogs & derivatives*
  • Dinoprost / therapeutic use*
  • Double-Blind Method
  • Female
  • Glaucoma, Open-Angle / drug therapy*
  • Humans
  • Intraocular Pressure / drug effects*
  • Latanoprost
  • Male
  • Middle Aged
  • Ocular Hypertension / drug therapy
  • Ophthalmic Solutions
  • Ophthalmoscopy
  • Prospective Studies
  • Prostaglandins F, Synthetic / administration & dosage
  • Prostaglandins F, Synthetic / therapeutic use*
  • Tonometry, Ocular
  • Treatment Outcome
  • Visual Acuity

Substances

  • Antihypertensive Agents
  • Ophthalmic Solutions
  • Prostaglandins F, Synthetic
  • isopropyl unoprostone
  • Latanoprost
  • Dinoprost