ACTRN12609000067279招募中未知
Prospective, parallel-group, randomised, open label, bilateral daily wear study to investigate bacterial contamination of regular contact lens cases when used in conjunction with marketed and investigational contact lens.
CIBA VISIO0 个研究点目标入组 80 人开始时间: 2009年1月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Be 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;
- •Be 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;
- •Be correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •Be experienced or may be inexperienced at wearing contact lenses
排除标准
- •Pre-existing ocular irritation, injury or condition that would preclude contact lens fitting and safe wearing of contact lenses;
- •any systemic disease that adversely affects ocular health;
- •any active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- •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;
- •previous corneal refractive surgery;
- •contraindications to contact lens wear;
- •currently enrolled in another clinical trial;
- •participation in a clinical trial within the previous 2 weeks for dispensing studies;
- •pregnant women are excluded from the trial - formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
研究者
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