NCT00349856已完成3 期
Dispensing Overnight Study in Lenses
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary objective of this trial is to assess safety of the investigational
研究概览
简要总结
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.
详细描述
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has had an oculo-visual examination in the last 2 years.
- •Is between 18-45 years old and has full legal capacity to volunteer.
- •Has read and understood the Information Consent Letter
- •Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
- •Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
- •Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
- •Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
- •Has refractive astigmatism of <= 1.00 diopters
- •Has clear corneas and ocular clinical findings considered to be "normal".
排除标准
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
- •Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
- •Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
- •Has never worn contact lenses before.
- •Has corneal distortion resulting from rigid lens wear.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of clinical or research study.
结局指标
主要结局
The primary objective of this trial is to assess safety of the investigational
时间窗: study visits, three monthly
次要结局
- The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.(study visits, three monthly)
研究者
研究点 (2)
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