NCT01416272终止不适用
Twelve Month Clinical Evaluation of KeraSoft IC Soft Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Comfort
研究概览
简要总结
The objective of this twelve month dispensing study is to evaluate the clinical performance, particularly comfort and vision, of KeraSoft IC Soft Contact Lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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 participated and completed a previous study (ROC2-10-078).
- •Is Keratoconic
排除标准
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Is not correctable to 20/50 or better in each eye with contact lenses.
- •Has greater than Grade 2 slit lamp exam findings.
- •Has any atypical scar for a keratoconic or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring that, in the Investigator's judgment, does not interfere with contact lens wear are eligible for this study.
- •Has any neovascularization within the central 4mm of the cornea.
结局指标
主要结局
Comfort
时间窗: 4 visits over 1 year
Symptoms and complaints measured on an analog scale
次要结局
- Visual Acuity - Low Contrast(4 visits over 1 year)
- Visual Acuity - High Contrast(4 visits over 1 year)
研究者
研究点 (2)
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