NCT01019564撤回不适用
Complete Easy Rub Comparative Efficacy Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
研究概览
简要总结
The aim of this trial is to assess Complete Easy Rub compared to a competitor multi-purpose solution in terms of lens cleanliness, subjective response and ocular response, when lenses are worn bilaterally on a daily wear basis for two months.
The hypotheses for this trial are:
- Lens cleanliness measures between solutions will be no different.
- Subjective ratings between solutions will be no different.
- Ocular response between solutions will be no different.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Be at least 18 years old, male or female;
- •Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- •Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
- •Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •Able to successfully wear one of the lens types to be used in this study on a daily wear (DW) basis in conjunction with any multi-purpose contact lens care solution (not including hydrogen peroxide-based systems) for at least one month prior to allocation of test or control solution;
排除标准
- •Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
- •Any systemic disease that adversely affects ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjögrens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- •Use of, or a need for, concurrent category S3 and above ocular medication at enrolment and/or during the study;
- •Use of, or a need for, any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance either in an adverse manner or beneficial manner at enrolment and/or during the study
结局指标
主要结局
Evaluation of lens cleanliness of test and control solutions when used with soft lenses at the end of the manufacturer-recommended replacement interval.
时间窗: Day 30
次要结局
未报告次要终点
研究者
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