Clinical Comparison of Two Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Overall Quality of Vision
研究概览
简要总结
The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
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
- •Understand and sign an Informed Consent Form;
- •Successful wear of daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- •Willing to stop wearing habitual contact lenses for the duration of study participation;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Anterior segment infection, inflammation, or abnormality or disease that contraindicates contact lens wear, as determined by the Investigator;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- •Refractive, ocular, or intraocular surgery, as specified in the protocol;
- •Eye condition or injury, as specified in the protocol;
- •Current or history of intolerance, hypersensitivity, or allergy to any component of the study products;
- •Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- •Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
- •Currently wearing clariti® 1 day contact lenses;
- •Habitually wearing monovision or multifocal lenses during the last 3 months;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DD T2, then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
干预措施: verofilcon A contact lenses (Device)
DD T2, then Clariti 1 Day
Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality.
干预措施: somofilcon A contact lenses (Device)
Clariti 1 Day, then DD T2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
干预措施: verofilcon A contact lenses (Device)
Clariti 1 Day, then DD T2
Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality.
干预措施: somofilcon A contact lenses (Device)
结局指标
主要结局
Overall Quality of Vision
时间窗: Day 8, each product
Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated.
次要结局
未报告次要终点