NCT07557030尚未招募不适用
Optimization for Toric Contact Lenses
CooperVision International Limited (CVIL)1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年5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
- 45
- 试验地点
- 1
- 主要终点
- Subjective assessment of optimization of Toric lenses
研究概览
简要总结
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
详细描述
To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •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 have spherical refractive error at the corneal plane between +4.00 to -7.00DS
- •They have refractive astigmatism at the corneal plane of 0.75 to 2.25DC in one eye.
- •They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye
- •They are a current soft contact lens wearer or have previous experience of successful soft contact lens wear in the past 3 years.
排除标准
- •Is participating in any concurrent clinical or research trial.
- •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 pseudophakic or aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
研究组 & 干预措施
Lens 1 ( stenfilcon A)
Experimental
All participants will be randomized to wear lens A
干预措施: Lens 1 ( stenfilcon A ) (Device)
Lens 2 ( comfilcon A)
Experimental
All participants will be randomized to wear lens B
干预措施: Lens 2 ( comfilcon A ) (Device)
结局指标
主要结局
Subjective assessment of optimization of Toric lenses
时间窗: At the End of Baseline 15 minutes of daily wear
Proportion of eyes in which the optimized toric lens cylinder axis determined by the subjective method agrees with that determined by the objective method within ±10 degrees (measured at a single time point).
次要结局
未报告次要终点
研究者
研究点 (1)
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