临床试验/NCT00657579

NCT00657579已完成2 期

A Randomized, Double-Masked, Parallel-Group, Dose-Response Trial of DE-104 Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Santen Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家开始时间: 2008年4月14日最近更新: 2009年3月16日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Santen Pharmaceutical Co., Ltd.
试验地点: 1

研究概览入排标准研究组 & 干预措施研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

研究设计

研究类型: Interventional

入排标准

年龄范围: 20 Years 至 74 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diagnosed with primary open-angle glaucoma or ocular hypertension.
•Provided signed, written informed consent.
•If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

排除标准

•Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
•Presence of any abnormality or significant illness that could be expected to interfere with the study.

研究组 & 干预措施

1

Experimental

干预措施: DE-104 ophthalmic solution, low concentration (Drug)

2

Experimental

干预措施: DE-104 ophthalmic solution, medium concentration (Drug)

3

Experimental

干预措施: DE-104 ophthalmic solution, high concentration (Drug)

4

Placebo Comparator

干预措施: DE-104 vehicle (Drug)

研究者

发起方

Santen Pharmaceutical Co., Ltd.

申办方类型

Industry

研究点 (1)

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