Performance of Two Daily Disposable Multifocal Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Subjective Visual Acuity
研究概览
简要总结
This study will compare the performance of two daily disposable multifocal soft contact lenses.
详细描述
This is a double-masked, randomized, crossover, 1-week, real world dispensing study, where participants will wear two designs of daily disposable soft multifocal contact lenses for 5-7 days each.
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
- •They are at least 18 years of age.
- •They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
- •They habitually use soft contact lenses (multifocal soft contact lenses, sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction,) and have worn lenses at least 3 days a week for at least the past six months.
- •They have a minimum reading add of +0.75DS (based on their spectacle refraction)
- •They have spherical equivalent refractive error between +6.00 to -10.00DS at the corneal plane and refractive astigmatism of no greater than -0.75DC in each eye.
- •They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye.
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
研究组 & 干预措施
Lens A then Lens B
Participants will wear the Test Lenses in both eyes for one week and then cross over to the Control Lenses in both eyes for one week.
干预措施: Lens A (kalfilcon A) (Device)
Lens B then Lens A
Participants will wear the Control Lenses in both eyes for one week and then cross over to the Test Lenses in both eyes for one week.
干预措施: Lens B (stenfilcon A) (Device)
结局指标
主要结局
Subjective Visual Acuity
时间窗: Through study completion, approximately 4 hours
High contrast high luminance (HCHL) distance binocular visual acuity (logMAR)
次要结局
未报告次要终点