NL-OMON50780已完成不适用
A Phase 1 Study to Evaluate the Safety and Tolerability of BYON5667 Eye Drops in Healthy Subjects - CS0364 Byondis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Byondis B.V.
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy male and female subjects, aged from 18 to 75 years at the time of
- •signing informed consent.
- •Presence of two functional eyes.
- •Good physical and mental health.
- •Female subjects of childbearing potential: an acceptable effective method of
- •contraception must be used during the trial until the end-of-study (EOS ).
排除标准
- •Presence or history of ocular disease or ocular trauma, or history of ocular
- •surgery including laser-therapy, or ocular signs or symptoms of systemic
- •disease , including current or prior pathology of eyelid or tear duct .
- •Amblyopia and color blindness are allowed.
- •Recent (within 2 months prior to signing informed consent) or current use of
- •eye drops, or other (systemic) medication that may affect the eye according to
- •the summary of product characteristics.
- •Use of contact lenses within 14 days before Day 1 and for the duration of the
- •Known active microbial, fungal or viral infection if deemed clinically
- •significant by the investigator.
- •Subject is pregnant or lactating.
研究者
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