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


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


METHODS
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.


CONCLUSIONS
These results indicate that Tafluprost is clinically useful in the treatment of NTG.
Kuwayama
Yasuaki
Y
Department of Ophthalmology, Osaka Koseinenkin Hospital, Japan.
Komemushi
Sadao
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007429:Intraocular Pressure; D057066:Low Tension Glaucoma / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D015990:Placebo Effect; D011460:Prostaglandins F / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
D009883:Ophthalmic Solutions; D011460:Prostaglandins F; C485333:tafluprost