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Phase III, 24‐month study investigating the efficacy and safety of tafluprost vs latanoprost in patients with open‐angle glaucoma or ocular hypertension
Author(s) -
UUSITALO HMT,
PILLUNAT LE,
BAUDOUIN C,
TRAVERSO C,
BERGSTRÖM A,
JENSSEN FT,
ZAGORSKI Z,
NESHER R
Publication year - 2008
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2008.529.x
Subject(s) - latanoprost , medicine , ocular hypertension , open angle glaucoma , glaucoma , ophthalmology , adverse effect , anesthesia
Purpose This double‐masked, active‐controlled, parallel‐group, multinational, multicentre, phase III, 24‐month study, conducted in 49 centres across 8 countries, investigated the efficacy and safety of tafluprost 0.0015% vs latanoprost 0.005% (once‐daily at 20:00) in 533 patients with open‐angle glaucoma or ocular hypertension. Methods The primary endpoints were change from baseline IOP after 24 months (1.5 mmHg non‐inferiority limit [tafluprost‐latanoprost]) and safety. Results Both treatments yielded a substantial IOP reduction, that was sustained for 24 months (tafluprost ‐7.1 mmHg; latanoprost ‐7.7 mmHg; n=402). Non‐inferiority was shown with ANOVA and almost reached with ANCOVA (upper limits of the 95% CI for the treatment difference were 1.38 and 1.52, respectively; RM models). Most ocular adverse events were mild and comparable between groups (48% vs 44%). Conclusion This 24‐month phase III study demonstrated that both tafluprost and latanoprost yielded a substantial reduction in IOP that was sustained for 24 months, and a similar safety profile.Commercial interest