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临床试验/EUCTR2015-002507-28-AT
EUCTR2015-002507-28-AT进行中(未招募)1 期

Effect of benzalkonium chloride containing eye drops on the conjunctival bacterial flora of dry eye patients. - Dry Eye BAC conjunctiva

Medical University of Vienna0 个研究点目标入组 40 人开始时间: 2015年6月23日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -Men and women aged between 18 and 75 years.
  • -Signed and dated written informed consent.
  • -History of dry eye syndrome for at least 3 months
  • -Tear Break Up Time (BUT) = 10 seconds or Schirmer I test = 10 mm and = 2mm
  • -Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
  • - Recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 32
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 8

排除标准

  • -History or presence of ocular disease judged by the investigator as incompatible with the study.
  • -Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period.
  • -Wearing of contact lenses.
  • -Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • -Participation in a clinical trial in the 3 weeks preceding the first study day
  • -Pregnancy, lactation.

研究者

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