【ChiCTR-ONC-14004780】對原發性開角型青光眼、原發性閉角型青光眼或高眼壓病人施用0.0015% Tafluprost（他氟前列素）滴眼液後的24小時眼球內壓概況的研究

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基本信息

登记号

ChiCTR-ONC-14004780

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2014-06-10

临床申请受理号

靶点

适应症

Primary Open Angle Glaucoma, Primary Angle Closure Glaucoma, Ocular Hypertension

试验通俗题目

對原發性開角型青光眼、原發性閉角型青光眼或高眼壓病人施用0.0015% Tafluprost（他氟前列素）滴眼液後的24小時眼球內壓概況的研究

试验专业题目

對原發性開角型青光眼、原發性閉角型青光眼或高眼壓病人施用0.0015% Tafluprost（他氟前列素）滴眼液後的24小時眼球內壓概況的研究

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

對原發性開角型青光眼、原發性閉角型青光眼或高眼壓病人施用0.0015% Tafluprost（他氟前列素）滴眼液後的24小時眼球內壓概況的研究

试验分类

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试验类型

单臂

试验分期

Ⅳ期

随机化

盲法

试验项目经费来源

Santen Pharmaceutical Co., Ltd.

试验范围

目标入组人数

实际入组人数

第一例入组时间

2014-06-24

试验终止时间

1990-01-01

是否属于一致性

入选标准

1) Primary open angle glaucoma, primary angle closure glaucoma or ocular hypertension; 2) Above those who are currently on anti-glaucoma medication (beta-blocker, carbonic anhydrase inhibitor or their combination) and insufficiently controlled; 3) Baseline IOP is 21mmHg or higher (for PACG patient, IOP is to be 21mmHg or higher after laser iridotomy or laser iridoplasty is conducted); 4) Those who can visit the clinic on the designated day as instructed by the physician.；

排除标准

1) History of intra-ocular surgery (not including laser iridotomy or laser iridoplasty conducted for PACG patients); 2) In case of primary angle closure, laser iridotomy or laser iridoplasty within one month prior to giving the informed consent is conducted; 3) Patients who are treated by prostaglandin analogues or its combinations; 4) History of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the investigational product; 5) Presence of any corneal disorder that may interfere with accurate IOP measurement using applanation tonometry; 6) Presence of corneal disorder that may interfere with accurate 24 hour IOP measurement using contact lens device; 7) Patients who are treated by steroids.(e.g. dexamethasone, hydrocortisone sodium succinate, prednisolone acetate); 8) Female patients who are pregnant, nursing or planning a pregnancy; 9) Patients wearing glasses with metal frames; 10) Patients with severe dry eye syndrome.；

研究者信息

研究负责人姓名

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试验机构

Santen Pharmaceutical Co., Ltd.

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

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