ACTRN12620001033932已完成未知
Prospective, single-masked (participant), randomised, crossover, bilateral wear, dispensing trial to assess the visual performance of monthly multifocal contact lenses in presbyopes.
Menicon Co. Ltd., Japan0 个研究点目标入组 26 人开始时间: 2020年10月12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
- 26
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
- 40 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.
- •Age 40 and above, male or female.
- •Willing to comply with the clinical trial protocol as directed by the Investigator.
- •Agree not to participate in other clinical research for the duration of this clinical trial.
- •Have ocular health findings considered to be normal” and which would not prevent the participant from safely wearing contact lenses.
- •Contact lens wear experience in the past 5 years.
- •Best corrected spectacle acuity of at least 6/7.5.
- •Have no more than 1.00 D of astigmatism.
- •Can be fitted with multifocal soft contact lenses within the power range available.
- •Able to obtain a binocular contact lens high contrast visual acuity of at least 6/7.5 with study contact lenses.
- •Willing and able to wear each study contact lens for about one month on a daily wear basis, for at least 5 days per week and 7 hours per day.
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, immunosuppressive 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.
- •Corneal distortion resulting from previous hard or rigid lens wear or keratoconus.
- •Use of or a need for concurrent category S3 and above ocular medication at enrolment.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Previous corneal refractive surgery or cataract surgery.
- •Contraindications to contact lens wear.
- •Known allergy or intolerance to ingredients in any of the clinical trial products.
- •Currently enrolled in another contact lens or lens care solution clinical trial within the last two weeks.
- •Currently wearing one of the contact lenses used in the study.
- •Pregnancy* or lactating at time of enrolment.
- •The Investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil 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 enough.
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