Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream BID for the Treatment of Signs and Symptoms of Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Mean change from baseline in the VAS score at Day 28 visit.
研究概览
简要总结
This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of 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
- •Male or female, 18 years of age or older at the Screening Visit
- •Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
- •Diagnosis of dry eye
排除标准
- •Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
- •History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
- •History of, or active iritis or uveitis in either eye
- •Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment
研究组 & 干预措施
Pilocarpine Ophthalmic Topical Cream, Dose 1
Pilocarpine Ophthalmic Topical Cream, Dose 1
干预措施: Pilocarpine Ophthalmic Topical Cream, Dose 1 (Drug)
Pilocarpine Ophthalmic Topical Cream, Dose 2
Pilocarpine Ophthalmic Topical Cream, Dose 2
干预措施: Pilocarpine Ophthalmic Topical Cream, Dose 2 (Drug)
Pilocarpine Ophthalmic Topical Cream, Dose 3
Pilocarpine Ophthalmic Topical Cream, Dose 3
干预措施: Pilocarpine Ophthalmic Topical Cream, Dose 3 (Drug)
Placebo Ophthalmic Topical Cream
Placebo Ophthalmic Topical Cream
干预措施: Placebo Ophthalmic Topical Cream (Drug)
结局指标
主要结局
Mean change from baseline in the VAS score at Day 28 visit.
时间窗: Baseline and Day 28
Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort)
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
时间窗: Baseline and Day 28
Mean change from baseline in Fluorescein Staining at the Day 28 visit.
次要结局
- Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits(Baseline and Days 4, 8, and 14)