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临床试验/ACTRN12618000196246
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

发起方
Brien Holden Vision Insitute

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