NCT04899518已完成2 期
A Phase 2b/3, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease (OASIS-1)
Allysta Pharmaceutical1 个研究点 分布在 1 个国家目标入组 922 人开始时间: 2021年5月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 922
- 试验地点
- 1
- 主要终点
- Corneal fluorescein staining
研究概览
简要总结
Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with Dry Eye Disease
详细描述
Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Two Concentrations (0.4% and 1%) of ALY688 Ophthalmic Solution in Subjects with 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
- 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
- •Dry eye disease for > 3 months meeting specific sign and symptom criteria
- •Best corrected visual acuity of +0.6 logMAR or better
- •Willing to sign informed consent and attend study visits
- •Willing to comply with contraception requirements
排除标准
- •Unable to meet specific sign and symptom criteria
- •Signs of ophthalmic allergic, inflammatory or infection conditions
- •Use of contact lenses
- •Anatomic abnormalities preventing accurate study assessments
- •Use of medications that influence eye dryness
- •Recent ophthalmic surgery
- •Unwilling to suspend current treatments for dry eye disease
研究组 & 干预措施
Vehicle Ophthalmic Solution
Placebo Comparator
干预措施: ALY688 Ophthalmic Solution (Drug)
ALY688 Ophthalmic Solution Concentration 1
Experimental
干预措施: ALY688 Ophthalmic Solution (Drug)
ALY688 Ophthalmic Solution Concentration 2
Experimental
干预措施: ALY688 Ophthalmic Solution (Drug)
结局指标
主要结局
Corneal fluorescein staining
时间窗: 8 weeks
Difference between ALY688 Ophthalmic Solution 0.4% and vehicle
次要结局
未报告次要终点
研究者
研究点 (1)
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