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[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].

AbstractPURPOSE:
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.
AuthorsYasuaki Kuwayama, Sadao Komemushi, Tafluprost Multi-center Study Group
JournalNippon Ganka Gakkai zasshi (Nippon Ganka Gakkai Zasshi) Vol. 114 Issue 5 Pg. 436-43 (May 2010) ISSN: 0029-0203 [Print] Japan
PMID20545217 (Publication Type: Clinical Trial, Phase III, English Abstract, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Ophthalmic Solutions
  • Prostaglandins F
  • tafluprost
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Humans
  • Intraocular Pressure
  • Low Tension Glaucoma (drug therapy, physiopathology)
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Placebo Effect
  • Prostaglandins F (administration & dosage, adverse effects)
  • Treatment Outcome
  • Young Adult

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