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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

    /

    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
    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

    /

    试验项目经费来源

    Santen Pharmaceutical Co., Ltd.

    试验范围

    /

    目标入组人数

    15

    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
    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

    /

    联系人通讯地址

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