临床试验/NCT01452009

NCT01452009撤回3 期

Three Month Safety and Efficacy Study of TRAVATAN® vs Travoprost Ophthalmic Solution, 0.004%

Alcon Research0 个研究点开始时间: 2011年11月最近更新: 2012年2月10日

适应症

干预措施

试验速览

阶段: 3 期
状态: 撤回
发起方: Alcon Research
主要终点: Efficacy: mean IOP Efficacy as measured by mean IOP

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A multi-center, observer-masked, randomized, parallel group efficacy and safety study of TRAVATAN® versus a new formulation of Travoprost Ophthalmic Solution, 0.004%

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients 18 years of age or older
•Either gender
•Any race/ethnicity
•Diagnosed with open-angle glaucoma (including patients with pseudoexfoliation and pigment dispersion) or ocular hypertension

排除标准

•Patients with any form of glaucoma other than open-angle glaucoma.
•Patients with a central cornea thickness greater than 620 μm
•Patients with Shaffer angle Grade < 2
•Patients with a cup/disc ratio greater than 0.80
•Patients with severe central visual field loss
•Best-Corrected Visual Acuity score worse than 55 ETDRS letters (20/80 Snellen equivalent)
•Chronic, recurrent or severe inflammatory eye disease
•Clinically significant or progressive retinal disease
•Other ocular pathology

研究组 & 干预措施

Travoprost Ophthalmic Solution, 0.004% (New Formulation)

Experimental

干预措施: Travoprost Ophthalmic Solution, 0.004% (New Formulation) (Drug)

TRAVATAN®

Active Comparator

TRAVATAN® administered one drop once daily

干预措施: TRAVATAN® (Drug)

结局指标

主要结局

Efficacy: mean IOP Efficacy as measured by mean IOP

时间窗: 3 months

次要结局

未报告次要终点

研究者

发起方

Alcon Research

申办方类型

Industry

责任方

Sponsor

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