Clinical Assessment of Two Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 27
- 主要终点
- Least Squares Mean Distance VA (logMAR) With Study Lenses
研究概览
简要总结
The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.
详细描述
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.
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
- 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 approved Informed Consent form;
- •Willing and able to attend all scheduled study visits as required by the protocol;
- •Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day;
- •Manifest cylinder less than or equal to 0.75 diopter (D) in each eye;
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any eye condition that contraindicates contact lens wear, as determined by the Investigator;
- •Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator;
- •Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
- •Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- •Current or prior Biofinity contact lens wear in the past 3 months prior to consent.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Least Squares Mean Distance VA (logMAR) With Study Lenses
时间窗: Day 30, each study product
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
次要结局
未报告次要终点