NCT01900249已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca
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
- 204
- 试验地点
- 20
- 主要终点
- Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
研究概览
简要总结
The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A history of dry eye (based on the date of initial dry eye symptoms)
- •Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms
- •Corneal fluorescein staining score of at least 2 in the inferior region
排除标准
- •History of, or a concurrent clinically significant illness, medical condition (other than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study.
- •Use of ophthalmic cyclosporine within 45 days of Visit
- •Use of any topical ophthalmic steroid within 2 weeks of Visit
- •Have worn contact lenses or anticipate using contact lenses during the study.
- •Have a condition or be in a situation that 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.
- •Have a history of alcohol or substance abuse that, in the judgment of the Investigator, may impair or risk the subject's full participation in the study.
研究组 & 干预措施
R348 Ophthalmic Solution, 0.2%
Active Comparator
R348 Ophthalmic Solution, 0.2%
干预措施: R348 Ophthalmic Solution, 0.2% (Drug)
R348 Ophthalmic Solution, 0.5%
Active Comparator
R348 Ophthalmic Solution, 0.5%
干预措施: R348 Ophthalmic Solution, 0.5% (Drug)
Placebo
Placebo Comparator
Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change of Corneal Fluorescein Staining of the Inferior Cornea Region.
时间窗: Baseline to Week 12
Change from baseline (Visit 3) of inferior region CFS score at 12 weeks. Inferior region CFS score range 0-4, where '0' represents no fluorescein staining and '4' represents severe staining on the cornea.
次要结局
未报告次要终点
研究者
研究点 (20)
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