NCT02040623已完成2 期
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 for the Treatment of Keratoconjunctivitis Sicca in Patients With Chronic Ocular Graft Versus Host Disease
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
- 35
- 试验地点
- 2
- 主要终点
- Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
研究概览
简要总结
- To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to subjects evaluated by objective and subjective measures.
- To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for 12 weeks to subjects.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.
- •Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening of dry eye symptoms for at least 1 month prior.
- •Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1 month.
- •Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other region.
- •Total lissamine green conjunctival staining score (according to a modified National Eye Institute grading system) of ≥ 2.
排除标准
- •Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive regimen), medical condition, or laboratory abnormality
- •Used topical ophthalmic cyclosporine within 45 days.
- •Used any topical ophthalmic steroid within 2 weeks.
- •Used autologous serum eye drops within 2 weeks.
研究组 & 干预措施
R348 Ophthalmic Solution, 0.2%
Active Comparator
R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
干预措施: R348 Ophthalmic Solution, 0.2% (Drug)
R348 Ophthalmic Solution, 0.5%
Active Comparator
R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
干预措施: R348 Ophthalmic Solution, 0.5% (Drug)
Placebo
Placebo Comparator
Placebo Ophthalmic Solution 2 drops per eye twice a day
干预措施: Placebo Ophthalmic Solution (Other)
结局指标
主要结局
Change From Baseline (Visit 1) of Total Corneal Fluorescein Staining Score at 12 Weeks.
时间窗: Baseline to 12 weeks
Change from baseline (Visit 1) of total CFS score at 12 weeks. Total CFS score range 0-20, where '0' represents no fluorescein staining of any region and '20' represents severe staining the entire cornea.
次要结局
未报告次要终点
研究者
研究点 (2)
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