American journal of ophthalmology · 2016
Randomized, Controlled, Phase 3 Trials of Carteolol/Latanoprost Fixed Combination in Primary Open-Angle Glaucoma or Ocular Hypertension.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Yamamoto Tetsuya, Ikegami Toru, Ishikawa Yuji, Kikuchi Satoru, OPC-1085EL 1 & 2 Study Groups
Аннотация
PURPOSE: To assess the intraocular pressure (IOP)-lowering effects and safety of a carteolol/latanoprost fixed combination drug (OPC-1085EL) vs latanoprost (Study 1) and carteolol (Study 2) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).
DESIGN: Multicenter, randomized, evaluator-masked (Study 1)/double-masked (Study 2), parallel-group studies.
METHODS: Setting: Twenty-eight clinical sites (Study 1) and 19 clinical sites (Study 2) in Japan.
STUDY POPULATION: Outpatients with bilateral POAG or OH whose predose IOP was 18 to <35 mm Hg in the study eye after 4 weeks' treatment with latanoprost (Study 1) or carteolol (Study 2) (defined as baseline).
INTERVENTION: In Study 1, 237 patients applied OPC-1085EL (n = 118) or latanoprost (n = 119) for 8 weeks. In Study 2, 193 patients applied OPC-1085EL (n = 78), carteolol (n = 78), or carteolol/latanoprost concomitant therapy (n = 37) for 8 weeks.
MAIN OUTCOME MEASURE: Adjusted mean IOP reduction at predose from baseline to week 8.
RESULTS: In Study 1, the adjusted mean IOP reductions (95% confidence interval [CI]) were 2.9 (2.5-3.3) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and latanoprost groups, respectively (P < .0001). In Study 2, the adjusted mean IOP reductions (95% CI) were 3.5 (3.1-3.9) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and carteolol groups, respectively (P < .0001). All adverse drug reactions of OPC-1085EL observed in both studies were mild in severity and only 1 patient in each study discontinued because of an adverse drug reaction.
CONCLUSIONS: OPC-1085EL is superior to latanoprost or carteolol alone in terms of lowering IOP, and was well tolerated.
DESIGN: Multicenter, randomized, evaluator-masked (Study 1)/double-masked (Study 2), parallel-group studies.
METHODS: Setting: Twenty-eight clinical sites (Study 1) and 19 clinical sites (Study 2) in Japan.
STUDY POPULATION: Outpatients with bilateral POAG or OH whose predose IOP was 18 to <35 mm Hg in the study eye after 4 weeks' treatment with latanoprost (Study 1) or carteolol (Study 2) (defined as baseline).
INTERVENTION: In Study 1, 237 patients applied OPC-1085EL (n = 118) or latanoprost (n = 119) for 8 weeks. In Study 2, 193 patients applied OPC-1085EL (n = 78), carteolol (n = 78), or carteolol/latanoprost concomitant therapy (n = 37) for 8 weeks.
MAIN OUTCOME MEASURE: Adjusted mean IOP reduction at predose from baseline to week 8.
RESULTS: In Study 1, the adjusted mean IOP reductions (95% confidence interval [CI]) were 2.9 (2.5-3.3) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and latanoprost groups, respectively (P < .0001). In Study 2, the adjusted mean IOP reductions (95% CI) were 3.5 (3.1-3.9) mm Hg and 1.6 (1.2-2.0) mm Hg in the OPC-1085EL and carteolol groups, respectively (P < .0001). All adverse drug reactions of OPC-1085EL observed in both studies were mild in severity and only 1 patient in each study discontinued because of an adverse drug reaction.
CONCLUSIONS: OPC-1085EL is superior to latanoprost or carteolol alone in terms of lowering IOP, and was well tolerated.
Предметные рубрики MeSH
Adrenergic beta-AntagonistsAdultAgedAged, 80 and overAntihypertensive AgentsCarteololDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlaucoma, Open-AngleHumansIntraocular PressureLatanoprostMaleMiddle AgedOcular HypertensionOphthalmic SolutionsProstaglandins F, SyntheticRetrospective StudiesTime FactorsTreatment OutcomeYoung Adult