A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
研究概览
简要总结
The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.
详细描述
Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.
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
- 是
入选标准
- •Normal subjects:
- •No known history of dry eye disease.
- •Non-contact lens wearer.
- •No current use of artificial tears or any other dry eye treatment.
- •Dry eye patients:
- •At least a 6 month history of dry eye.
- •Non-contact lens wearer.
- •Uses artificial tears.
- •Experiences persistent ocular discomfort.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit
- •Severe Sjogren's Syndrome.
- •Lid function abnormalities.
- •Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit
- •History of corneal surgery including refractive surgeries.
- •History of glaucoma or ocular hypertension
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Durezol
Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
干预措施: Difluprednate 0.05% ophthalmic emulsion (Drug)
Vehicle
Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.
干预措施: Difluprednate vehicle (Other)
结局指标
主要结局
Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
时间窗: Baseline, up to 4 weeks
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
次要结局
未报告次要终点