NCT05313412已完成不适用
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Ease of Lens Insertion
研究概览
简要总结
This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.
详细描述
This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses. Each lens type is worn for approximately six hours on separate study days, in random sequence.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are aged between 18 and 40 years.
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They have successfully worn contact lenses within six months of starting the study.
- •They can be satisfactorily fitted with the study contact lenses.
- •They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.
- •They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.
- •They own and habitually wear single vision spectacles.
- •They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.
- •They agree not to participate in other clinical research while enrolled on this study.
排除标准
- •They have an ocular disorder which would normally contraindicate contact lens wear.
- •They have a systemic disorder which would normally contraindicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •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.
- •They are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.
- •They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.
结局指标
主要结局
Ease of Lens Insertion
时间窗: 6 hours
Ease of Lens Insertion is measured on a scale of 0-100 (0-Unmanageable, Lenses impossible to insert; 100-Excellent. No problems with lens insertion)
次要结局
未报告次要终点
研究者
研究点 (1)
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