Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
2015年5月5日 更新者:Johnson & Johnson Vision Care, Inc.
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
研究概览
研究类型
介入性
注册 (实际的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Waterloo、Ontario、加拿大、N2L 3G1
- Centre for Contact Lens Research
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
17年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- They are of legal age (17 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Habitual silicone hydrogel
Habitual contact lens wear.
|
contact lens
|
|
实验性的:narafilcon A
Silicone hydrogel daily disposable contact lens
|
隐形眼镜
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Limbal Hyperemia
大体时间:At 2 weeks and 4 weeks
|
Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe.
The analysis is the average grade over all time frames.
|
At 2 weeks and 4 weeks
|
|
Lens Comfort
大体时间:At 3,7,10,13,17,21,24, and 27 days
|
Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames. |
At 3,7,10,13,17,21,24, and 27 days
|
|
Upper Lid Margin Staining
大体时间:At 2 weeks and 4 weeks.
|
Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe.
The analysis is the average grade over all time frames.
|
At 2 weeks and 4 weeks.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tarsal Roughness
大体时间:At 2 weeks and 4 weeks
|
Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe.
The analysis is the average grade over all time frames.
|
At 2 weeks and 4 weeks
|
|
Tarsal Hyperemia
大体时间:At 2 weeks and 4 weeks.
|
Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
|
At 2 weeks and 4 weeks.
|
|
Corneal Staining
大体时间:At 2 weeks and 4 weeks.
|
A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch.
The analysis is the average grade over all time frames.
|
At 2 weeks and 4 weeks.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年6月1日
初级完成 (实际的)
2008年9月1日
研究完成 (实际的)
2008年9月1日
研究注册日期
首次提交
2008年6月27日
首先提交符合 QC 标准的
2008年7月1日
首次发布 (估计)
2008年7月2日
研究记录更新
最后更新发布 (估计)
2015年5月21日
上次提交的符合 QC 标准的更新
2015年5月5日
最后验证
2015年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.