DE-117 Spectrum 5 Study
赞助:
Santen Inc.
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | October 3, 2018 | ||
| 首次发布日期e ICMJE | October 5, 2018 | ||
| 最后更新发布日期 | October 5, 2018 | ||
| 预计研究开始日期 ICMJE | September 27, 2018 | ||
| 预计主要完成日期 | October 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Intraocular pressure[ Time Frame: Month 3 ] Reduction in IOP in Latanoprost low/non-responder subjects |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | DE-117 Spectrum 5 Study | ||
| 正式标题 ICMJE | An Open-Label, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution 0.002% in Latanoprost Low/Non-Responder Subjects Diagnosed With Primary Open-Angle Glaucoma or Ocular Hypertension - Spectrum 5 Study | ||
| 简要概况 | Santen will evaluate the intraocular pressure (IOP) lowering effect and efficacy of DE-117 ophthalmic solution 0.002% in latanoprost/non-responder subjects diagnosed with POAG or OHT |
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| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
150 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | November 30, 2019 | ||
| 预计主要完成日期 | October 31, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Patients with Primary Open-Angle Glaucoma or Ocular Hypertension in one or both eyes. - Provide signed written informed consent. - Diagnosis of POAG or OHT in both eyes. - Qualifying corrected visual acuity in each eye. - Qualifying central corneal thickness in each eye. - Qualifying Day 1 IOP measurement at 3 time-points in both eyes after latanoprost Run-in Period. - Qualifying Anterior chamber angle. Exclusion Criteria: - Patients who cannot safely discontinue use of Ocular Hypotensive Medications during Washout. - Patients with prior exposure to DE-117. - History of ocular surgery specifically intended to lower IOP - Advanced glaucoma in either eye. - Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry. - Any ocular surgery or ocular laser treatment within 180 days prior to Visit 1 (Screening) and throughout the study in either eye. - Females who are pregnant, nursing, or planning a pregnancy. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Santen Inc. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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