Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Distance VA (logMAR) With Study Lenses
研究概览
简要总结
The overall objective of this clinical study is to describe the clinical performance of the TOTAL30® soft contact lens compared to the ACUVUE® OASYS® with HYDRACLEAR PLUS (AOHP) soft contact lens in a daily wear modality.
详细描述
Subjects will be expected to attend 3 visits and wear the study contact lenses at least 5 days per week and at least 8 hours per day. On Visits 2 and 3, subjects will be expected to wear the study lenses at least 6 hours prior to the study visit. The expected total duration of subject participation in the study will be approximately 1.5 months. This study will be conducted in the United Kingdom (UK).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Currently wearing any commercial spherical soft contact lenses with at least 3 months wearing experience.
- •Willing to wear the study lenses for a minimum of 5 days per week and 8 hours per day.
- •Willing to NOT use rewetting/lubricating drops at any time during the study.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Participation in a clinical trial within the previous 14 days or currently enrolled in any clinical trial.
- •Habitual AOHP contact lens wearers (in the past 3 months).
- •Monovision wear during the study.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance VA (logMAR) With Study Lenses
时间窗: Dispense (Day 0) and Follow-Up (Day 28 for TOTAL30, Day 14 for AOHP) (each wear period)
Distance visual acuity (VA) was assessed for each eye individually with study lenses in place using letter charts. VA was measured in 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. The follow-up visit for TOTAL 30 occurred approximately 28 days after the baseline visit. The follow-up visit for AOHP occurred approximately 14 days after the baseline visit. No formal hypothesis was formulated for the primary effectiveness endpoint of distance VA; hence, no inferential testing was performed.
次要结局
未报告次要终点