Vistakon Investigational Lens Worn as a Single Use Daily Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
This study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •eyes must be best-corrected to a visual acuity of 20/30 or better in each eye
- •must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study
- •distance spherical contact lens prescription must be within the range available for the study
排除标准
- •systemic diseases which may interfere with contact lens wear
- •ocular infection or clinically significant ocular disease
- •any previous intraocular surgery
- •grade 2 or greater slit lamp findings
- •currently pregnant or lactating
- •more than 1.00D of refractive astigmatism in either eye
研究组 & 干预措施
narafilcon B
contact lens
干预措施: narafilcon B (Device)
etafilcon A
contact lens
干预措施: etafilcon A (Device)
结局指标
主要结局
Visual Acuity (VA)
时间窗: after 1 month
Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.
Corneal Edema at Month 1
时间窗: after 1 month of lens wear
Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Slit Lamp Findings - Corneal Neovascularization
时间窗: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Infiltrates
时间窗: after 1 month of lens wear
Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.
Slit Lamp Findings - Tarsal Abnormalities
时间窗: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Corneal Staining
时间窗: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.
Slit Lamp Findings - Injection
时间窗: after 1 month of lens wear
Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.
Average Wear Time
时间窗: after 1 month of lens wear
Slit Lamp Findings - Corneal Edema
时间窗: after 1 week of lens wear
Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.
Subject Reported Symptoms
时间窗: after 1 month of lens wear
Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.
次要结局
未报告次要终点