ACTRN12620000423910已完成未知
Prospective, double-masked, randomised, parallel, bilateral wear dispensing clinical trial to compare the clinical performance of two daily disposable contact lenses.
Brien Holden Vision Institute0 个研究点目标入组 78 人开始时间: 2020年3月30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
- 78
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.
- •* Spherical prescription range of -10.00DS to +6.00DS and cylinder less than or equal to 0.75DC)
- •* Correctable to at least 6/7.5 (20/25) or better in each eye with contact lenses.
- •* Must be an experienced contact lens wearer.
- •* Be able to insert and remove contact lenses.
排除标准
- •* Any pre-existing ocular irritation, injury or condition (including infection or inflammation) 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 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 impacting ocular health, vision or systemic conditions/medications (as noted above), which may impact habitual ocular health and vision and the ability to perform the relevant testing required for the current clinical trial.
- •* Pregnancy.
- •* The Investigator may, at his/her discretion, exclude anyone who they believe may not be able to fulfill the clinical trial requirements or it is believed to be in the participant’s best interests.
- •*Formal testing of pregnancy is not required. A participant’s verbal report is sufficient.
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