A Comparison of Daily Disposable Contact Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 248
- 试验地点
- 19
- 主要终点
- Overall Comfort
研究概览
简要总结
This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.
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 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.
研究组 & 干预措施
narafilcon A
spherical soft contact lens worn as a daily disposable modality for one week
干预措施: narafilcon A (Device)
nelfilcon A
spherical soft contact lens worn as a daily disposable modality for one week
干预措施: nelfilcon A (Device)
nelfilcon A
spherical soft contact lens worn as a daily disposable modality for one week
干预措施: narafilcon A (Device)
结局指标
主要结局
Overall Comfort
时间窗: at 1 week of wear.
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured Limbal Hyperemia
时间窗: at 1 week of wear.
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
次要结局
- End of Day Comfort(at 1 week of wear)
- Initial Comfort(at 1 week)
- Inferior Region Corneal Staining(at 1 week of wear)
- Overall Handling(at 1 week of wear)
- How Comfortable Eyes Feel at the End of the Day(at 1 week wear)