On-Eye Evaluation of Contact Lens Rotation Marks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)
研究概览
简要总结
The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.
详细描述
Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Sign Informed Consent document.
- •Best corrected distance visual acuity (VA) greater than or equal to 20/25 in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
- •Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
- •History of herpetic keratitis.
- •Slit-lamp findings greater than grade 2 at baseline.
- •Any use of systemic or ocular medications for which CL wear could be contraindicated.
- •Inactive corneal neovascularization greater than 1 millimeter of penetration.
- •A clinically significant dry eye not responding to treatment.
- •History of refractive surgery.
- •Participation in a clinical study within the previous 30 days.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)
时间窗: Day 1
Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."
次要结局
未报告次要终点