ACTRN12618000196246已完成1 期
Short term evaluation of the ocular response to caffeine eye-drops and caffeine plus atropine eye-drops in healthy volunteers..
Brien Holden Vision Insitute0 个研究点目标入组 20 人开始时间: 2018年2月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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 instil each of the test eye drops daily for 5 days and follow the clinical trial visit schedule as directed by the Investigator.
- •Have ocular health findings considered to be normal”.
排除标准
- •Any pre-existing ocular irritation, injury or condition, including infection or disease.
- •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.
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial.
- •Previous corneal refractive surgery.
- •Contraindications to caffeine such as high blood pressure, heart conditions and ADHD
- •Known allergy or intolerance to ingredients to caffeine.
- •Contact lens wearer
- •Pregnancy and breastfeeding.*
- •Currently enrolled in another clinical trial.
- •The Investigator may, at his/her 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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