[Intraocular pressure lowering effect of 0.0015% tafluprost as compared to placebo in patients with normal tension glaucoma: randomized, double-blind, multicenter, phase III study]

Nippon Ganka Gakkai Zasshi. 2010 May;114(5):436-43.
[Article in Japanese]

Abstract

Purpose: To compare the efficacy and safety of 0.0015% tafluprost ophthalmic solution (Tafluprost) with Placebo ophthalmic solution (Placebo) in normal tension glaucoma (NTG).

Setting: Total of 94 patients enrolled in a randomized, double-blind, parallel-group and multicenter study.

Method: Patients with NTG were randomly assigned to either Tafluprost or Placebo. Both ophthalmic solutions were instilled once a day in the morning for 4 weeks.

Results: Mean intraocular pressure (IOP) changes from baseline were -4.0 +/- 1.7 mmHg in Tafluprost administered patients and -1.4 +/- 1.8 mmHg in Placebo administered patients at 4 weeks, with a statistically significant difference (p<0.001). IOP change at 4 weeks, % IOP reduction at 2 and 4 weeks were also significantly greater in Tafluprost than in Placebo. A total of 51.0% in Tafluprost treated group and 8.9% in Placebo treated group reported adverse drug reactions.

Conclusion: These results indicate that Tafluprost is clinically useful in the treatment of NTG.

Publication types

  • Clinical Trial, Phase III
  • English Abstract
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Humans
  • Intraocular Pressure*
  • Low Tension Glaucoma / drug therapy*
  • Low Tension Glaucoma / physiopathology
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Placebo Effect
  • Prostaglandins F / administration & dosage*
  • Prostaglandins F / adverse effects
  • Treatment Outcome
  • Young Adult

Substances

  • Ophthalmic Solutions
  • Prostaglandins F
  • tafluprost