NCT02858284终止不适用
A Multi-Center, Randomized, Double-Masked, 8-week Pilot Study Evaluating the Safety and Efficacy of the TUG (Therapeutic Ultrasound for Glaucoma) Compared to Sham in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
EyeSonix0 个研究点目标入组 25 人开始时间: 2016年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 主要终点
- Change in mean diurnal IOP
研究概览
简要总结
The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary open angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes
- •Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study
- •Be willing to provide written informed consent
- •Be willing and able to follow instructions
- •A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential)
排除标准
- •Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye
- •Prior or anticipated concurrent use of an investigational drug or device
- •Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
- •Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation
结局指标
主要结局
Change in mean diurnal IOP
时间窗: Week 4 (Visit 5) and Week 8 (Visit 7)
Change in mean IOP
时间窗: through subject study completion; average 2 months
Change in IOP from baseline
时间窗: through subject study completion; average 2 months
次要结局
未报告次要终点
研究者
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