NCT00851734已完成1 期
A Phase 1 Dose-Escalation Study To Assess the Safety and Tolerability of LX214 Ophthalmic Solution in Healthy Volunteers, Followed By an Open-Label Evaluation of LX214 Ophthalmic Solution in Patients With Keratoconjunctivitis Sicca
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ocular irritation
研究概览
简要总结
This is a first-in-man study for the purpose of determining the safety and tolerability of LX214 ophthalmic solution in healthy volunteers and in patients with 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No systemic disease as determined by a physical examination, clinical laboratory evaluation, and an ECG
- •Schirmer's I Test ≥ 10mm/5 minutes with anesthesia
- •Corrected Snellen acuity of 20/40 or better in both eyes
排除标准
- •Subjects diagnosed with any ocular disease other than refraction error
- •Subjects with intraocular pressure >21 mmHg
- •Use of a contact lens within 7 days prior to administration of the first dose
- •Subjects with history of ocular surgery
- •Subjects with a history of laser refractive surgery
研究组 & 干预措施
LX214 0.02%
Experimental
LX214 ophthalmic solution 0.02%
干预措施: voclosporin ophthalmic solution (Drug)
LX214 0.2%
Experimental
干预措施: voclosporin ophthalmic solution (Drug)
placebo
Placebo Comparator
placebo
干预措施: voclosporin ophthalmic solution (Drug)
结局指标
主要结局
ocular irritation
时间窗: 12 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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