NCT07829419尚未招募不适用
Clinical Performance Evaluation of Two Monthly Replacement Silicone Hydrogel Multifocal Toric Lens Designs in Habitual Soft Contact Lens Wearers
CooperVision International Limited (CVIL)3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Ease of handling
研究概览
简要总结
To compare the performance of two leading soft multifocal Toric contact lenses.
详细描述
Prospective, randomized, subject-masked, bilateral crossover dispensing study.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person is eligible for inclusion in the study if they are:
- •Participants at least 40 years of age.
- •Participants requiring lens powers within the range available for the study lenses.
- •Participants with a spherical refractive error at the corneal plane of plano to -6.
- •Participants with a minimum reading add of +0.75DS (based on their spectacle refraction at screening). At least 12 participants will be enrolled per add group: low (+0.75 to +1.25D), medium (+1.50 to +1.75D), and high (+2.00 to +2.50).
- •Participants with refractive astigmatism at the corneal plane of 0.75 to 2.00DC.
- •Best spectacle corrected visual acuity greater than or equal to 20/25 (less than or equal to LogMAR 0.1).
- •Habitually using soft contact lenses (multifocal soft contact lenses, sphere or toric lenses for monovision, or sphere or toric 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.
- •Anticipating being able to wear contact lenses for at least 8 hours a day, 5 days a week.
- •Willing and able to follow instructions and maintain the appointment schedule.
排除标准
- •Anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear.
- •Any active anterior segment ocular disease that would contraindicate contact lens wear.
- •The use of systemic or ocular medications that would contraindicate contact lens wear.
- •History of herpetic keratitis.
- •History of refractive surgery or irregular cornea.
- •Slit lamp findings that are more serious than grade 1 (see ISO 11980 scale).
- •Inactive (i.e. ghost) vessels greater than 1 mm of penetration into the cornea.
- •Participation of the participant in a contact lens or contact lens care product clinical trial within the previous 90 days if involving orthokeratology, 30 days if involving extended wear, rigid gas permeable corneal and scleral lenses, or 15 days if involving daily disposable, daily wear soft lenses.
研究组 & 干预措施
Lens A then Lens B
Experimental
Participants will wear the Test Lenses in both eyes for one month and then cross over to the Control Lenses in both eyes for one month.
干预措施: Lens A ( comfilcon A) (Device)
Lens B and then Lens A
Experimental
Participants will wear the Control Lenses in both eyes for one month and then cross over to the Test Lenses in both eyes for one month.
干预措施: Lens B ( lehfilcon A) (Device)
结局指标
主要结局
Ease of handling
时间窗: 1 month
Ease of handling for lens removal (0-100)
次要结局
未报告次要终点
研究者
研究点 (3)
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