ACTRN12609000447257终止未知
Prospective study investigating the change of ocular mucin expression on the ocular surface and in tear fluid due to contact lens wear and its correlation with contact lens clinical performance in neophytes and regular wearers with minimal lens wear in the previous one month.
Institute for Eye Research0 个研究点目标入组 30 人开始时间: 2009年6月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 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 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;
- •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.
排除标准
- •Regular contact lens wearers;
- •Pre-existing ocular irritation that would preclude contact lens fitting;
- •Any ocular condition that may preclude safe wearing of contact lenses e.g. active corneal infection, severe dry eye, reduced corneal sensitivity, exophthalmos/lagophthalmos, facial nerve palsy;
- •Active corneal infection (bacterial, viral, fungal or protozoan) or any active ocular disease such as iritis, corneal edema or corneal dystrophies, including anterior membrane dystrophy that would affect wearing of contact lenses;
- •Use of any of the following medications (including steroids) up to 12 weeks prior to start of the clinical trial, or during the course of the trial:
- •Ocular medication, category S3 and above;
- •Any systemic or topical medications that will affect ocular physiology or the performance of the lenses e.g. anti-acne medications such as Roaccutane and corticosteroid or immunosuppressant medications such as Hydrocortisone, Prednisolone;
- •Any systemic disease that may affect ocular health e.g. diabetes, Graves disease, and auto-immune diseases such as ankolysing spondylitis, multiple sclerosis, Sjogrens syndrome and systemic lupus erythematosis;
- •Conditions such as systemic hypertension do not automatically exclude prospective participants;
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •Previous corneal refractive surgery;
- •Any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would affect the wearing of contact lenses;
- •Contraindications to hydrogel contact lens wear;
- •Currently enrolled in another clinical trial;.
- •Be pregnant or breast feeding;*.
- •Allergy or intolerance to topical anaesthetics.
- •*verbal report of pregnancy by the participant is sufficient, formal testing not required
研究者
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