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【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

基本信息
登记号

ChiCTR-ONC-14004780

试验状态

正在进行

药物名称

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药物类型

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规范名称

/

首次公示信息日的期

2014-06-10

临床申请受理号

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靶点

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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
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
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
试验类型

单臂

试验分期

Ⅳ期

随机化

NA

盲法

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试验项目经费来源

Santen Pharmaceutical Co., Ltd.

试验范围

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目标入组人数

15

实际入组人数

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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

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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
试验机构

Santen Pharmaceutical Co., Ltd.

研究负责人电话
研究负责人邮箱
研究负责人邮编

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联系人通讯地址
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