ACTRN12612000187842尚未招募未知
Prospective, single-masked, randomised, contralateral investigation comparing DAILIES TOTAL 1[RegisteredTradeMark] to ACUVUE[RegisteredTradeMark] OASYS[TradeMark] on subjective comfort with twenty-five myopic participants.
Brien Holden Vision Institute0 个研究点目标入组 25 人开始时间: 2012年2月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
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 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, male or female.
- •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 experienced in wearing contact lenses.
- •Be able to insert and remove contact lenses.
- •Be willing to not wear contact lenses for at least 48 hours before each stage of the clinical trial (after informed consent).
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, Sjogrens syndrome and systemic lupus erythematosus. 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 at enrolment and/or during the clinical 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 at enrolment and/or during the clinical trial. NB: Systemic antihistamines are allowed on an as needed basis”, provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Previous corneal refractive surgery.
- •Contraindications to contact lens wear.
- •Known allergy or intolerance to ingredients in any of the clinical trial products.
- •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.
研究者
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