30 Day Trial Fitting of a New Bifocal Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 4
- 主要终点
- Visual Acuity
研究概览
简要总结
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).
详细描述
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).
Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must provide written informed consent.
- •The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- •At least 40 years of age and no more than 70 years of age.
- •≤ 4.00 D of corneal astigmatism.
- •≤ 4.00 D of refractive astigmatism.
- •Refractive error range +20.00 DS to -20.00 DS
- •Keratometry readings within 40 to 50D.
- •Clear, healthy corneas with no irregular astigmatism.
- •Normal, healthy conjunctiva in both eyes.
- •Free of active ocular disease. Refractive error and presbyopia are permitted.
- •Be a current or former (within the last 12 months) contact lens wearer.
- •Best-corrected near and distance visual acuity better than or equal to 20/25.
排除标准
- •Irregular corneal astigmatism.
- •Corneal scarring unless off line-of-site and well healed.
- •Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- •Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 times per week is permitted.
- •Systemic disease that would interfere with contact lens wear.
- •Currently pregnant or lactating (by self-report).
- •History of strabismus or eye movement disorder, including exophoria at near that is 4D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- •Active allergies that may inhibit contact lens wear.
- •Upper eyelid margin at or above the superior limbus.
- •History of ocular or lid surgery.
结局指标
主要结局
Visual Acuity
时间窗: 30 days
LogMAR visual acuity
次要结局
- Comfort(30 days)