NCT06438601已完成不适用
A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Subjective Distance Vision
研究概览
简要总结
This study aims to compare the short-term clinical performance of the two study contact lenses.
详细描述
The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are aged 35 years or over and have capacity to volunteer.
- •They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They agree not to participate in other clinical research for the duration of this study.
- •They are currently wearing soft contact lenses or have done so within the past 12 months.
- •They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).
- •They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.
- •They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.
- •They can be satisfactorily fitted with the study lenses.
- •They own a wearable pair of spectacles.
排除标准
- •They have an ocular disorder which would normally contraindicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medications such as eye drops or ointment.
- •They have had cataract surgery.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
- •They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Subjective Distance Vision
时间窗: At the end of 15 minutes of daily wear
Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).
次要结局
未报告次要终点
研究者
研究点 (1)
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