ACTRN12610000336088已完成未知
A prospective, open label, bilateral, clinical trial to investigate daily, morning cleaning of silicone hydrogel contact lenses worn during three months extended wear as a strategy for reducing adverse events associated with contact lens wear in neophyte and experienced lens wearers
Brien Holden Vision Institute0 个研究点目标入组 100 人开始时间: 2010年4月28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
- 100
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
- Non-randomised 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
- •Able to read, 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 vision that 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
- •-Have previously experienced a severe or significant contact lens related ocular adverse event including microbial keratitis (MK), infiltrative keratitis (IK), contact lens acute red eye (CLARE) and/or contact lens peripherial ulcer (CLPU).
- •-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, Sjogrens syndrome and systemic lupus erythematosis. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants;
- •-An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •-Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- •-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 risk providing a false positive.
- •N.B. Systemic antihistamines are allowed on an ‘as needed basis’, provided they are not used prophylactically during the trial;
- •-Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •-Previous corneal refractive surgery;
- •-Any rigid gas permeable (RGP) or orthokeratology lens wear within the previous 2 weeks;
- •-Contraindications to contact lens wear;
- •-Currently enrolled in a clinical trial
- •-Participated in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
- •-Be pregnant
研究者
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