The Comparative Clinical Performance of the Etafilcon A Lens and the DAILIES AquaComfort Plus Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
This study seeks to evaluate the clinical performance of a recently improved daily disposable contact lens to an established daily disposable contact lens that contains a wetting agent.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are of legal age (18 years) and capacity to volunteer.
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- •They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- •They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- •They have successfully worn contact lenses within six months of starting the study. -
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 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 has keratoconus.
- •They are pregnant or lactating.
- •They have grade 2 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 any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- •They have diabetes.
- •They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Visual Acuity
时间窗: 2-week
Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.
Subjective Lens Comfort
时间窗: 2-week
Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.
次要结局
- Subject-reported Overall Product Performance(2-week)
- Optimum Lens Fit(Baseline, 1-week, 2-week)