NCT01957670撤回不适用
Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome
Lacrima Medical LTD2 个研究点 分布在 1 个国家开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Lower Tear Meniscus Height using Optical Coherence Tomography
研究概览
简要总结
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Male or female, 18 years of age and over at screening
- •Diagnosis of mild to moderate Dry Eye, as defined by:
- •Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND
- •Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
- •OSDI score of ≥12 and OSDI score of <33
排除标准
- •Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
- •Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection
- •Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
- •Receipt of any type of topical artificial eye drops within 3 days prior to screening
- •Receipt of topical cyclosporine eye drops within 3 months prior to screening
结局指标
主要结局
Lower Tear Meniscus Height using Optical Coherence Tomography
时间窗: up to 8 hours
次要结局
- Visual Analog Scale score(up to 8 hours)
研究者
研究点 (2)
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