Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Vertical Movement of Contact Lens in Downgaze
研究概览
简要总结
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
详细描述
This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
- •The subject must have ≤ 1.50 D of corneal astigmatism.
- •The subject should have clear, healthy corneas.
- •The subject should have a normal, healthy conjunctiva in both eyes.
- •The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
- •The subject must provide written informed consent.
- •The subject must appear willing and able to adhere to the instructions set forth in this protocol.
排除标准
- •No irregular corneal astigmatism is permitted.
- •No pterygia or corneal scarring that would interfere with contact lens wear.
- •No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
- •The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
结局指标
主要结局
Vertical Movement of Contact Lens in Downgaze
时间窗: After 15 minutes of on-eye settling
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
次要结局
- Comfort questionnaire(After 15 minutes of on-eye settling)
- Movement of contact lens with blink(After 15 minutes of on-eye settling)
- Visual Acuity(After 15 minutes of on-eye settling)