NCT04096898Unknown不适用
Clinical Trial to Determine Whether Senofilcon A Lenses Provide Relief of Symptoms and Signs in Patients With Moderate to Severe Dry Eye Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index (OSDI)
研究概览
简要总结
A clinical trial using Senofilcon A daily lenses in the treatment of moderate to severe dry eye. This a comparison between signs and symptoms prior to and during treatment.
详细描述
32 patients with moderate to severe dry eye will be enrolled in this short-term proof of concept study to determine the efficacy in using soft lenses made of Senofilcon A in reducing signs and symptoms.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of moderate to severe dry eye associated with either Graft-versus-host disease (GVHD), Sjogren syndrome, idiopathic dry eyes, or minimal limbal cell deficiency
- •A baseline Schirmer tear test (1) of less than 5 mm at 5 minutes without anesthesia
- •Have a visual analog score for comfort of 50 or less (scale of 1-100, with 100 meaning perfect ocular comfort and 1 meaning severe ocular pain)
- •Ability or the resources to insert and remove the study lenses
- •An OSDI score greater than 42
- •A willingness to sign an informed consent
排除标准
- •No dry eyes or mild dry eyes
- •A baseline Schirmer tear test (1) of greater than 5 mm of wetting at 5 minutes
- •Dry eye comfort score of greater than 50 on a visual analog scale
- •Unable to insert or remove the study lenses (or have a family member do so)
- •Have an OSDI score less than 42
- •Has been diagnosed with neurotrophic keratopathy in either eye
- •Unwilling to enroll in the study, and unwilling to provide signed informed consent to participate in the study
结局指标
主要结局
Ocular Surface Disease Index (OSDI)
时间窗: 2 weeks
Patient questionaire
次要结局
未报告次要终点
研究者
Timothy T. McMahon, OD
Dr. Timothy T. McMahon
University of Illinois at Chicago
研究点 (2)
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