ACTRN12614000203651撤回2 期
eurostimulation to Increase Tear Production Measured Objectively via Schirmer Test in Adult Patients with Moderate to Severe Dry Eye Disease – A Multicenter Open-Label Study (Part 2)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 60
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients who completed the three month randomized controlled trial, ACTRN12613001110774
- •Willing to sign the informed consent and deemed capable of following the study protocol
排除标准
- •A change in an ocular or systemic disorder or condition during the previous study judged by the investigator to be incompatible with participation in the study, with patient safety, with the frequent assessments required by the study or confounding to the interpretation of study results
- •Be currently taking any medication known to cause ocular drying (e.g., cyclosporine, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blocking agents, diuretics, phenothiazines, steroids, etc.) that has not been used on a stable dosing regimen for 30 days prior to Day 0
- •Punctal plugs (participants with permanent occlusion of punctal ducts are eligible)
- •Contact lens use for the duration of the study
- •Participation in any clinical trial with a new active substance or a new device during the course of the study
- •Women who are pregnant, planning a pregnancy or nursing at study entry
研究者
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