Evaluation of ESBA105 in the Persistent Relief of Ocular Discomfort in Patients With Severe Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
详细描述
Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Ongoing physician diagnosis of dry eye for at least 6 months.
- •Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis.
- •Experience persistent ocular discomfort.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Contact lens wearers.
- •Severe Sjogren's Syndrome.
- •History of corneal surgery including refractive surgeries.
- •Intraocular surgery within 6 months of Visit
- •Intraocular or periocular injection within 6 months of Visit
- •Lid function abnormalities.
- •Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit
- •Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit
- •Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
时间窗: Up to 28 days
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
次要结局
未报告次要终点