ACTRN12609000230257尚未招募未知
A prospective, randomised, cross over, open label, bilateral design clinical trial to investigate the differences in the adhesion of various bacteria to a range of silicone hydrogel contact lenses worn by experienced contact lens wearers and to determine whether lens wear modulates adhesion
Institute for Eye Reseach0 个研究点目标入组 30 人开始时间: 2009年5月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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;
- •Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses at baseline;
- •Be experienced at wearing contact lenses at baseline;
- •Owns spectacles with current prescription.
排除标准
- •Pre-existing ocular irritation, injury or condition 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 and auto-immune diseases;
- •An 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 risk providing a false positive.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •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.
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