A Phase 1/2a, Randomized, Double-Masked, Vehicle-Controlled Study Evaluating the Safety and Exploratory Activity of Two Concentrations of ALY688 Ophthalmic Solution in Subjects With Dry Eye Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Corneal Fluorescein Staining
研究概览
简要总结
Clinical Trial Evaluating the Safety and Tolerability of ALY688 in Subjects with Dry Eye Disease
详细描述
This is a multi-center, randomized, double-masked Phase 1/2a trial designed to evaluate the safety and tolerability of ALY688 Ophthalmic Solution in subjects with moderate to mildly severe dry eye for 8 weeks with 6 scheduled clinic visits.
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 correct 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 infectious 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
ALY688 0.1%
ALY688 0.1% Ophthalmic Solution
干预措施: ALY688 0.1% (Drug)
Vehicle
Vehicle Ophthalmic Solution
干预措施: Vehicle (Drug)
ALY688 0.4%
ALY688 0.4%Ophthalmic Solution
干预措施: ALY688 0.4% (Drug)
结局指标
主要结局
Corneal Fluorescein Staining
时间窗: 8 weeks
Mean change from baseline in zonal corneal fluorescein staining score in study eye using a 0- to 4-unit clinical grading scale, with 0 being better and 4 being worse
Number of Subjects With Adverse Events
时间窗: 8 weeks
Subjects reporting any treatment-emergent adverse events
Eye Dryness Score (7-Day Average)
时间窗: 8 weeks
Mean change from baseline in eye dryness score (7-day average) using a 0- to 100-unit visual analog scale, with 0 being better and 100 being worse
次要结局
- Conjunctival Lissamine Green Staining(8 weeks)
- Symptom Assessment in Dry Eye (SAnDE) Score Assessment(8 weeks)
- Tear Film Break-up Time (TBUT)(8 weeks)
- Ocular Discomfort Score by Visual Analog Scale(8 weeks)
- Conjunctival Hyperemia Grading(8 weeks)
- Schirmer's Test(8 weeks)