NCT01118754已完成1 期
Phase I/II Prospective, Randomized, Double Masked, Parallel-Group, Multi-centered Study Assessing the Safety and Efficacy of Two Concentrations of DE-101 Compared to Placebo for the Treatment of Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 132
- 主要终点
- Ocular Symptom Severity
研究概览
简要总结
The purpose of this study is to evaluate if DE-101 ophthalmic suspension will safely and effectively improve signs and or symptoms of dry eye disease.
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
- Triple (Participant, 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 dry eye defined by protocol
- •18 years or older, and sign written informed consent
- •negative pregnancy test and utilizing reliable contraceptive throughout study
排除标准
- •use of any topical ocular medications
- •any ocular surgery within 90 days of study
- •laser refractive surgery within one year of study
- •ocular, lid disease/abnormalities that may interfere with the study
- •corneal transplants
- •uncontrolled systemic conditions
- •females who are pregnant or nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •participated in another drug trial within 30 days prior to study
研究组 & 干预措施
DE-101 ophthalmic suspension high dose
Experimental
干预措施: DE-101 ophthalmic suspension (Drug)
DE-101 ophthalmic suspension low dose
Experimental
干预措施: DE-101 ophthalmic suspension (Drug)
DE-101 ophthalmic suspension vehicle
Placebo Comparator
干预措施: DE-101 ophthalmic suspension (Drug)
DE-101 ophthalmic suspension vehicle
Placebo Comparator
干预措施: DE-101 ophthalmic suspension vehicle (Drug)
结局指标
主要结局
Ocular Symptom Severity
时间窗: 8 weeks
Total fluorescein corneal staining
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
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