ACTRN12608000609358已完成未知
Prospective, randomised, open label, contralateral, cross-over evaluation of tear lipid changes associated with daily wear of Acuvue Oasys and Purevision lenses used in conjunction with Aosept Plus and Optifree Replenish and correlation of findings with lens performance in up to 30 new and experienced contact lens wearers
Institute for Eye Research0 个研究点目标入组 30 人开始时间: 2008年12月4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
- Prevention
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 /A（—）
- 性别
- All
入选标准
- •Participants enrolled in the trial must:
- •Be 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;
- •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 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
- •Participants enrolled in the trial must NOT have:
- •Pre-existing ocular irritation that would preclude contact lens fitting;
- •Known allergies to any of the ingredients in products tested;
- •An ocular condition that may preclude safe wearing of contact lenses;
- •An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •A need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the trial;
- •Any systemic disease where fasting is contraindicated e.g. Type 1 diabetes, hypoglycaemia and any blood disorders (e.g. haemophilia)
- •Any systemic disease that may affect ocular health. Conditions such as systemic hypertension do not automatically exclude prospective participants;
- •Any systemic or topical medications up to 12 weeks prior to and during the trial that will affect ocular physiology or the performance of the lenses;
- •Had eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •Undergone corneal refractive surgery;
- •Any ocular injury or condition (including keratoconus, herpes keratitis and orthokeratology) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
- •Contraindications to contact lens wear;
- •Currently enrolled in another clinical trial or participated in contact lens clinical trial within 2 weeks;
- •Worn contact lenses for the past 2 weeks;
- •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.
研究者
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