ACTRN12609000812291已完成未知
Prospective, open labelled, randomised daily wear trial comparing the ocular response and product performance between 1 Day Acuvue Moist, 1 Day Acuvue TruEye and Acuvue Oasys contact lenses in new and experienced wearers
Alcon Laboratories0 个研究点目标入组 120 人开始时间: 2009年9月17日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
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
- •Participants in this 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;
- •- Has vision correctable to at least 6/12 (20/40) or better in each eye with contact lenses;
- •- may be experienced or inexperienced at wearing contact lenses.
排除标准
- •Participants in this trial must not have:
- •- 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;
- •- Use of or a need for concurrent category S3 and above ocular medication up to 12 weeks prior to and during the 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;
- •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 or participation in a ‘short term’ clinical trial within the previous 48 hours;
- •- Be pregnant
- •- Allergy or intolerance to topical anaesthetics
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