NCT06751225已完成不适用
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Subjective assessment of lens wear experience
研究概览
简要总结
This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
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
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
- •Subjects must have 20/20 or better best corrected visual acuity.
- •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)
- •Ability to give informed consent
- •Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits.
- •Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
- •Currently not using eye lubricating drops and willing to not use during study.
- •Either gender and 18-40 years of age.
- •Any racial or ethnic origin
排除标准
- •Any active ocular inflammation or infection.
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- •Are presbyopic and require or habitually uses reading glasses for near work
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- •History of refractive surgery
- •Meets the diagnosis of dry eye disease with OSDI screening score ≥
- •Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
- •Is pregnant or lactating or planning a pregnancy during enrollment in the study
- •Is participating in another clinical research study that includes invasive ocular tests
- •An inability to perform contact lens application and removal after instruction.
研究组 & 干预措施
Contact Lens Wear Experience
Experimental
One week replacement soft contact lenses will be worn for 3 weeks.
干预措施: One week replacement soft contact lenses (Device)
结局指标
主要结局
Subjective assessment of lens wear experience
时间窗: 3 weeks
VAS assessment of overall vision throughout the day. (0-100 scale; 0=unacceptable 100=excellent)
次要结局
未报告次要终点
研究者
Jennifer Fogt
Assistant Professor
Ohio State University
研究点 (1)
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