ACTRN12610000348055已完成未知
A prospective, single-group, open label, bilateral daily wear clinical trial to investigate microbial contamination of three contact lens cases (Sauflon i-clean [registered] antibacterial case, Sauflon silver barrel case and Sauflon regular flat case), and correlations between Demodex, ocular discomfort and ocular measures in contact lens wearers, when used in conjunction with marketed PureVision [trademark] contact lenses and Synergi multipurpose solution
Brien Holden Vision Institute0 个研究点目标入组 40 人开始时间: 2010年4月30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
- 40
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
- Treatment
- 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 and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •-Be at least 18 years old;
- •-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;
- •-Has vision 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
- •-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 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;
- •-Contraindications to contact lens wear;
- •-Currently enrolled in another clinical trial;
- •-Be pregnant*
- •The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the participant’s best interests.
- •* Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
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