AIR OPTIX® COLORS Registration Trial
2014年4月24日 更新者：CIBA VISION
The purpose of this study was to evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.
研究概览
详细说明
This study consisted of 7 scheduled visits conducted over a 3-month period.
Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
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
- 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:
- Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.
- Normal eyes and not using any ocular medications.
- Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.
- Manifest cylinder less than or equal to 0.75 diopter.
- Best spectacle corrected visual acuity greater than or equal to 20/25.
- Have current prescription glasses.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Anterior segment infection, inflammation, or abnormality.
- Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.
- Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.
- History of refractive surgery or irregular cornea.
- History of pathologically dry eye.
- Corneal vascularization greater than 1 millimeter of penetration.
- History of herpetic keratitis.
- Eye injury within 12 weeks immediately prior to enrollment in this trial.
- Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.
- Other protocol-defined exclusion criteria may apply.
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
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AIR OPTIX® COLORS
Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
彩色硅水凝胶隐形眼镜
其他名称：
|
|
有源比较器：AIR OPTIX® AQUA
Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
|
硅水凝胶隐形眼镜
其他名称：
|
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 |
|---|---|---|
|
隐形眼镜矫正距离单眼 Snellen 视力 (VA)（20/30 或更好）
大体时间：直到第 3 个月
|
对每只眼睛单独评估的视力。
参与者在佩戴研究镜片时阅读距离 Snellen 图表。
报告 VA 记录为 20/30 或更好的眼睛的百分比。
双眼对百分比都有贡献。
|
直到第 3 个月
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
整体舒适度的主观评价
大体时间：直到第 3 个月
|
总体舒适度，由参与者按照 10 分制评分，1 分为差，10 分为优秀。
参与者通过提供一个单一的评级来同时对双眼进行评级。
|
直到第 3 个月
|
|
整体视力的主观评价
大体时间：直到第 3 个月
|
总体视力，由参与者以 10 分制评分，1 分差，10 分优秀。
参与者通过提供一个单一的评级来同时对双眼进行评级。
|
直到第 3 个月
|
|
整体处理的主观评价
大体时间：直到第 3 个月
|
总体操作，由参与者以 10 分制评分，1 分表示困难，10 分表示容易。
参与者通过提供一个单一的评级来同时对双眼进行评级。
|
直到第 3 个月
|
|
Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)
大体时间：Up to Month 3
|
Lens fit, as assessed by the investigator for each eye individually.
Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -2=unacceptably tight.
The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported.
Lenses from both eyes contributed to the percentage.
|
Up to Month 3
|
|
Lens Centration (Centered, Slight Decentration)
大体时间：Up to Month 3
|
Lens centration, as assessed by the investigator for each eye individually.
Lens centration was rated on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration.
The combined percentage of lenses assessed as "centered" or "slight decentration" is reported.
Lenses from both eyes contributed to the percentage.
|
Up to Month 3
|
|
Dry Areas/Non-Wetting (None, Very Slight)
大体时间：Up to Month 3
|
Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually.
Dry areas/non-wetting was rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe.
The combined percentage of lenses assessed as "none" or "very slight" is reported.
Lenses from both eyes contributed to the percentage.
|
Up to Month 3
|
|
Front Surface Deposits (None, Very Slight)
大体时间：Up to Month 3
|
Front surface deposits on the contact lens, as assessed by the investigator for each eye individually.
Front surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe.
The combined percentage of lenses assessed as "none" or "very slight" is reported.
Lenses from both eyes contributed to the percentage.
|
Up to Month 3
|
|
Back Surface Deposits (None, Very Slight)
大体时间：Up to Month 3
|
Back surface deposits on the contact lens, as assessed by the investigator for each eye individually.
Back surface deposits were rated on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe.
The combined percentage of lenses assessed as "none" or "very slight" is reported.
Lenses from both eyes contributed to the percentage.
|
Up to Month 3
|
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。
赞助
调查人员
- 研究主任：Sharon Holden Thomas, OD、Alcon Research
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
2011年9月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年9月22日
首先提交符合 QC 标准的
2011年9月22日
首次发布 (估计)
2011年9月26日
研究记录更新
最后更新发布 (估计)
2014年5月8日
上次提交的符合 QC 标准的更新
2014年4月24日
最后验证
2014年4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.