Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Visual Analog Scale
研究概览
简要总结
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
详细描述
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investigators expect to enroll a relatively equal amount of former soft multifocal contact lens wearers who dropped out due to poor vision at distance or near and single vision wearers who dropped out due to poor near vision. The key endpoints include Visual Analog Scale survey of lens wear symptoms (comfort, dryness, vision) with contact lenses and assessment of the participant's quality of life with the Dailies TOTAL1 Multifocal® 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 38 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give informed consent.
- •Any gender.
- •Any racial or ethnic origin.
- •At least 38 years of age or older.
- •Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
- •Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
- •Spectacle sphere power range between +6.00 to -10.
- •Previously dropped out of contact lens wear due to vision or vision and discomfort.
- •Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI
排除标准
- •Current or active ocular inflammation or infection as determined by the Investigator.
- •Astigmatism ≥ 1.00 D in either eye.
- •History of previous eye surgery.
- •Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
- •Demonstration or history of corneal ectasia or keratoconus.
- •Pregnant or lactating
结局指标
主要结局
Visual Analog Scale
时间窗: 1 month
Visual Analog Scale survey of lens wear symptoms (vision) with contact lenses; percentage of participants with positive scores (\> 50).
Quality of Life Survey
时间窗: 1 month
Assessment of the participant's quality of life with the daily disposable multifocal contact lenses; percentage of participants with VAS scores greater than 50 on satisfaction survey.
次要结局
未报告次要终点
研究者
Jennifer Fogt
Principal Investigator
Ohio State University