NCT02326090已完成2 期
A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1.0% and 2.5% Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye
Herantis Pharma Plc.0 个研究点目标入组 161 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 主要终点
- Symptom Score
研究概览
简要总结
The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.
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
- Quadruple (Participant, 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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Have a subject reported history of dry eye;
- •Have a history of use or desire to use eye drops.
排除标准
- •Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
- •Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
- •Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
- •Have used Restasis® within 30 days of Visit 1;
- •Have any planned ocular and/or lid surgeries over the study period;
- •Be a woman who is pregnant, nursing or planning a pregnancy;
- •Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
- •Have a known allergy and/or sensitivity to the study drug or its components;
- •Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
- •Be unable or unwilling to follow instructions, including participation in all study assessments and visits.
研究组 & 干预措施
cis-UCA ophthalmic solution 2.5%
Active Comparator
One drop in each eye
干预措施: cis-UCA ophthalmic solution 2.5% (Drug)
Placebo ophthalmic solution
Placebo Comparator
One drop in each eye
干预措施: Placebo ophthalmic solution (Drug)
cis-UCA ophthalmic solution 1.0%
Active Comparator
One drop in each eye
干预措施: cis-UCA ophthalmic solution 1.0% (Drug)
结局指标
主要结局
Symptom Score
时间窗: Day 22 to 28
Corneal Fluorescein Staining
时间窗: Day 29
次要结局
未报告次要终点
研究者
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