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临床试验/ACTRN12616000539437
ACTRN12616000539437已完成未知

Effect of Manuka honey CycloPower ophthalmic micro-emulsion cream on ocular parameters in blepharitis compared with no treatment

The University of Auckland0 个研究点目标入组 53 人开始时间: 2016年4月27日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
53

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

  • Males or females
  • - Age 18 years or over
  • - Normal lid / lash anatomy, and closure
  • - Clinically significant signs of blepharitis and symptoms of dry eye

排除标准

  • - Contact lens wearers unwilling to remove lenses 48 hours prior to commencement of, and for the duration of, the study.
  • - Ocular surgery (such as refractive or cataract surgery) in either eye within 3 months of the screening visit
  • - A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.)
  • - The history or presence of any significant skin condition or disorder that might interfere with the study outcomes.
  • - The history or presence of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or patient safety such as a significant reduction in visual acuity e.g. less than 20/200; significant corneal or conjunctival scarring, pterygium or nodular pinguecula; current ocular infection or inflammation unrelated to dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection, etc.
  • - Known hypersensitivity to any of the components of the study preparation or bee products
  • - Active or uncontrolled severe systemic allergy, chronic seasonal allergies, rhinitis or sinusitis requiring treatment (i.e. antihistamines, decongestants, oral or aerosol steroids) at the time of screening
  • - Use of medication known to cause ocular drying (e.g., cyclosporine, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids, etc.) within 30 days of the screening visit
  • - Punctal plugs (unless permanent)
  • - Participation in any clinical trial with a new active substance or a new device during the past 30
  • - Women who are pregnant, planning a pregnancy or nursing at study entry.

研究者

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