A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Overall Comfort
研究概览
简要总结
The objective of the study was to compare the clinical performance of the two contact lenses when used in combination with three care systems.
详细描述
This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects were randomized to wear each lens and solution combination for a month in random sequence; that is for a total of six months.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are aged 18-50 and have capacity to volunteer.
- •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 are an existing wearer of reusable, single vision, spherical soft contact lenses.
- •They have a contact lens spherical prescription between -1.00 to - 6.50D (inclusive)
- •They have a spectacle cylindrical correction of -1.00D or less in each eye.
- •At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- •They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- •They agree not to participate in other clinical research for the duration of 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 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 are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- •They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), 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
Overall Comfort
时间窗: One Month
Overall Comfort will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort on Insertion
时间窗: One Month
Comfort on insertion will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
Comfort Before Removal
时间窗: One Month
Comfort before removal will be assessed using vertical visual analogue scales (0-100) (0 - Causes Pain. Cannot be tolerated, 20 -Very uncomfortable, very irritating or annoying, 40 - Slightly uncomfortable, just irritating or annoying, 60 - Comfortable. Noticeable but not irritating, 80 - Very comfortable. Just felt occasionally, 100 - Excellent. Cannot be felt).
次要结局
- Vision(One Month)
- Variable Vision(One Month)
- Dryness(One Month)
- Burning/Stinging(One Month)
- Vision at Night(One Month)
- Ocular Redness(One Month)
- Ease of Lens Insertion(One Month)
- Ease of Lens Removal(One Month)