ACTRN12618001901291已完成未知
Prospective, double-masked, randomized, crossover, bilateral wear dispensing trial to assess the effect of lens design on contact lens dissatisfaction in symptomatic, pre-presbyopic, contact lens wearers with a binocular vision order and / or contact lens discomfort.
Brien Holden Vision Institute0 个研究点目标入组 44 人开始时间: 2018年11月22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
- 44
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 40 Years（—）
- 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 between 18-40 years old, male or female.
- •Willing to comply with the clinical trial 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.
- •Be an experienced soft contact lens wearer.
- •Be myopic with less than or equal to 1.00 D of cylindrical power in either eye.
- •Be correctable to better than 0.20 logMAR in each eye with single vision contact lenses.
- •Be able to insert and remove contact lenses.
- •Score greater than or equal to 15 on the OSDI questionnaire at baseline, while wearing habitual contact lenses.
- •BVD Group: Have a binocular vision disorder profile at baseline, while wearing habitual contact lenses
- •CLD Group: Score greater than or equal to 12 on the CLDEQ-8 but not have a binocular vision disorder profile at baseline, while wearing habitual contact lenses.
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.
- •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 while wearing study lenses.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Previous corneal refractive surgery.
- •Previous surgery on the extra ocular muscles.
- •Contraindications to contact lens wear.
- •Known allergy or intolerance to ingredients in any of the clinical trial products.
- •Currently enrolled in another clinical trial.
- •Pregnancy*.
- •The Investigator may, at his 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 sufficient.
研究者
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