Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 675
- 试验地点
- 84
- 主要终点
- Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in an extended wear modality.
详细描述
Subjects will be expected to attend 9 office visits. The total expected duration of participation for each subject is approximately 12 months.
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
- Double (Participant, Investigator)
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
- •Able to understand and sign an Informed Consent Form.
- •Willing to attend all scheduled study visits as required per protocol.
- •Willing and able to wear assigned study lenses as required per protocol.
- •Successful wear of spherical daily wear or extended wear frequent replacement soft contact lenses in both eyes during the past 3 months for a minimum of 5 days per week.
- •Manifest cylinder ≤ 0.75 diopter (D) in each eye.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any eye infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •History of eye surgery, including refractive surgery.
- •Currently pregnant or breast-feeding.
- •Monovision contact lens wearers.
- •Daily disposable contact lens wearers.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Distance Visual Acuity (VA) With Study Lenses - Completed Eyes
时间窗: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up, Month 12 Follow-up
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes
时间窗: Day 1 Dispense; Hour 24 Follow-Up; Week 1 Follow-up; Month 1 Follow-up; Month 2 Follow-up; Month 3 Follow-up; Month 6 Follow-up; Month 9 Follow-up
Visual acuity (VA) was assessed for each eye individually with study lenses in place at a distance of 6 meters using a letter chart. VA was collected in Snellen and converted to logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
Proportion of Ocular Serious and Significant Non-serious Adverse Device Effects (ADEs)
时间窗: Up to Month 12
Calculated as the total number of eyes reporting at least one treatment-emergent, ocular, serious ADE or treatment-emergent, ocular, significant, non-serious ADE, divided by the total number of eyes enrolled and dispensed. An ADE was defined as any adverse event related to the use of the investigational medical device (LID015385) or control product (Biofinity).
次要结局
未报告次要终点