ACTRN12608000557336已完成未知
A prospective, randomised, open label, parallel group, cross-over design clinical trial to investigate protein and lipid deposition that mediate bacterial adhesion on the surface of silicone hydrogel contact lenses with use of different lens care solutions during daily and extended wear.
Institute for Eye Research0 个研究点目标入组 60 人开始时间: 2008年11月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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;
- •Have experienced an ocular adverse event that is not considered to be severe by the Investigator (Investigator discretion) or that is temporary in nature;
- •Is 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; active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •previously experienced a severe contact lens related adverse event (Investigator discretion), that is likely to affect their contact lens wear experience or present a significant safety risk during the trial;
- •any prescribed 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 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;pregnant or lactating women who are not able to complete the study (Investigator discretion).
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