NCT00596583已完成3 期
AQNA-DY001: A Double-Masked, Randomized Study of the Safety and Effectiveness of DYME as an Agent for Selective Staining of the Anterior Capsule During Cataract Surgery
Aqumen Biopharmaceuticals, N.A.20 个研究点 分布在 2 个国家目标入组 300 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
研究概览
简要总结
The primary objective of this study is to test the hypothesis that DYME is safe and effective as a drug to facilitate continuous curvilinear capsulorhexis (CCC) by selectively staining the anterior capsule. Secondary objectives are to compare the safety and effectiveness of DYME to that of a smaller dose of the same API.
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
- Quadruple (Participant, Care Provider, 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
- •Have a cataract sufficiently opaque/mature/brunescent that, in the surgeon's assessment,a dye could facilitate surgery;
- •Be aged at least 18 years old at the time of enrollment;
- •Be able to tolerate a surgical procedure for up to 3 hours;
- •Be in a medical condition suitable for cataract surgery;
- •Able and willing to participate in study examinations and visit schedule; and
- •Understand and freely consent to participate in the study.
排除标准
- •In either eye, ocular infection or inflammation within the past 3 months;
- •Known allergy to BBG 250;
- •Uncontrolled intercurrent diseases including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia;
- •Active treatment for cancer or systemic infection within the past month;
- •Active treatment with systemic corticosteroids within the past month;
- •Previous participation in this Study for the contralateral eye;
- •Participation in another clinical trial involving an investigational therapeutic during the past 30 days or 5.5 half-lives (if applicable), whichever is longer;
- •Unwillingness to participate in the study or inability to give informed consent; or
- •Any medical condition that in the opinion of the Investigator may compromise the research subject's safety or ability to participate in the study.
研究组 & 干预措施
High Dose
Active Comparator
干预措施: DYME (Drug)
Low Dose
Active Comparator
干预措施: DYME (Drug)
结局指标
主要结局
Optimal curvilinear capsulorrhexis with a single dose, as assessed by the surgeon based on the tissue dyed and subsequently removed.
时间窗: During surgery
Uncomplicated discharge
时间窗: one week post-op
次要结局
- Quality of stain(during surgery)
- Intra-ocular safety of DYME as measured by best corrected visual acuity, corneal endothelial cell count, intraocular pressure, presence/absence of retained dye, duration of surgery, and the absence of dye related adverse events(1-day and 1-week post-op)
研究者
研究点 (20)
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