NCT00333060终止2 期
Phase 2 Study of OT-551 Ophthalmic Solution to Prevent or Delay Progression of Nuclear Cataract Formation In Post-Vitrectomy Patients
Othera Pharmaceuticals16 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 164
- 试验地点
- 16
- 主要终点
- change in visual acuity
研究概览
简要总结
The purpose of this trial is to compare the ability of two doses of OT-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). Victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Imminent vitrectomy to repair macular holes or puckers
- •Ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery
- •Best corrected ETDRS visual acuity equivalent to Snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye
排除标准
- •Artificial lens or no lens in the surgical eye
- •Cataract (greater than slight opacity or thickness) in the surgical eye
- •Any other retinal abnormality which may be vision-threatening
- •Serious heart, kidney, or liver disease
- •Recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days)
- •Poorly controlled diabetes or unstable glaucoma
结局指标
主要结局
change in visual acuity
change in lens opacity
次要结局
未报告次要终点
研究者
研究点 (16)
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