An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Proportion of Eyes Successfully Fit
研究概览
简要总结
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
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 60 Years（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
Proportion of Eyes Successfully Fit
时间窗: Within 20 minutes of lens insertion
Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.
Lens Fit Decentration
时间窗: Within 20 minutes of lens insertion
Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.
Lens Tightness on Cornea With Manual Digit Push Up
时间窗: Within 20 minutes of lens insertion
Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.
次要结局
未报告次要终点