ACTRN12614000521628已完成未知
A prospective, unmasked, parallel clinical trial assessing silicone hydrogel and hydrogel contact lenses for clinical performance when used on a daily wear basis for one month
Brien Holden Vision Institute0 个研究点目标入组 400 人开始时间: 2014年5月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 400
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, male or female.
- •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.
- •May be an experienced or inexperienced lens wearer.
- •Be able to insert and remove contact lenses.
- •Be willing to undergo a 2 week wash-out with habitual correction between lens assessments.
排除标准
- •Any pre-existing ocular irritation, injury or condition (including infection or disease) 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, Sjorens syndrome and systemic lupus erythematosus. Conditions such as systemic hypertension and arthritis do not automatically exclude prospective participants.
- •Use of or a need for concurrent category S3 and above ocular medication at enrolment. However, such ocular medications can be prescribed as per standard optometric care during the clinical 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 or beneficial manner at enrolment and/or during the clinical trial.
- •NB: Systemic antihistamines are allowed on an as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Previous corneal refractive surgery.
- •Contraindications to contact lens wear.
- •Known allergy or intolerance to ingredients in any of the clinical trial products.
- •Currently enrolled in another clinical trial.
- •Pregnancy (Formal testing of pregnancy is not required. A participant’s verbal report is sufficient).
- •The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant’s best interests.
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