NCT00198536已完成2 期
Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 3
- 主要终点
- Ocular discomfort
研究概览
简要总结
The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome
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
- •Agree to avoid systemic & topical ophthalmic meds & disallowed meds
- •Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye
- •Diagnosis of moderate dry eye syndrome
排除标准
- •Uncontrolled ocular or systemic disease that could interfere with study
- •Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis
- •Contraindications or hypersensitivity to use of study meds or components
- •Wear contact lenses
- •Secondary dry eye to surgery
- •Eye surgery (including laser) within 6 months
- •Use of systemic or topical ophthalmic meds within 14 days
- •Punctal plugs in one or both eyes in place for <45 days
- •Permanent occlusion of the lacrimal puncta
研究组 & 干预措施
Ecabet 2.83%
Experimental
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
干预措施: Ecabet 2.83% (Drug)
Ecabet 3.70%
Experimental
Ecabet ophthalmic solution One drop in study eye 4 times daily for 90 days.
干预措施: Ecabet 3.70% (Drug)
Vehicle
Placebo Comparator
One drop of vehicle in study eye 4 times daily for 90 days.
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular discomfort
时间窗: Day 91
Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Tear Film Break-up Time (TFBUT)
时间窗: Day 91
Group mean change in time to tear break-up from pre-CAE to post-CAE.
Blink Rate
时间窗: Day 91
Group mean change in blinks/min from pre-CAE to post-CAE.
次要结局
未报告次要终点
研究者
研究点 (3)
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