ACTRN12609000431224已完成未知
A prospective, cross-over, randomised clinical trial to establish the ocular comfort profile with and without lens wear over a 12 hour period and to assess the changes in the profile in experienced wearers when lens are inserted at different times of the day and worn for 4 hours, with AIR OPTIX (trademark) AQUA contact lenses
CIBA VISIO0 个研究点目标入组 30 人开始时间: 2009年6月10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
- 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
- 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;
- •Is correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •Be able to insert and remove contact lenses;
- •Experienced contact lens wearer;
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 at enrolment and/or during the study;
- •Use of or a need for any systemic medication or topical medications (including systemic antihistamines) 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 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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