ACTRN12609000430235已完成4 期
A prospective, single-masked, cross-over, randomised clinical trial assessing ocular comfort and ocular changes with and without lens replacement during the day with AIR OPTIX (trademark) AQUA contact lenses worn by experienced wearers over three days
CIBA VISIO0 个研究点目标入组 20 人开始时间: 2009年6月10日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 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;
- •Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •Be an experienced contact lens wearer;
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, 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 at enrolment and/or during the study;
- •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;
- •Participation in a clinical trial within the previous 2 weeks for dispensing studies and 48 hours between in-house studies;
- •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.
- •N.B. Whilst pregnant or lactating women are not excluded from the trial, they must be able to complete the study.
研究者
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