ACTRN12613001075774已完成1 期
eurostimulation to Increase Tear Production Measured Objectively via Schirmer Test in Adult Patients with Mild to Severe Dry Eye Disease - Pilot Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 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
- 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
- •Willing to sign the informed consent and deemed capable of following the study protocol
- •Basal Schirmer tear test of less than or equal to 15 mm; Schirmer test at least twice or at least 10 mm higher after nasal stimulation with cotton swab
- •Baseline Ocular Surface Disease Index score of at least 13
- •Normal lid anatomy, blinking function and closure
- •Corrected visual acuity of 20/200 (Snellen equivalent) or better in each eye
排除标准
- •Individuals with a history or presence of any systemic disorder or condition that is not stabilized or would likely interfere with the interpretation of study results or subject safety
- •Presence of severe systemic allergy or acute or chronic rhinitis or sinusitis
- •Individuals with the presence or history of any ocular disorder or condition that would likely interfere with the interpretation of study results or subject safety
- •Nasal, orbital or lacrimal trauma, surgery, tumour or cancer
- •Significant corneal or conjunctival scarring of any aetiology
- •Known hypersensitivity to one of the components of the study device or procedural medications
- •Patients with a history of chronic or recurrent epistaxis
- •Participation in any clinical trial with a new active substance or a new device during the past 3 months
- •Women who are pregnant, planning a pregnancy or nursing at study entry
研究者
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