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
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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