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 Presbyopia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Binocular Distance Corrected Near Visual Acuity (DCNVA)
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 Presbyopia.
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
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presbyopic male or female 40-55 years of age
- •Willing and able to provide written informed consent on the IRB/IEC approved informed consent form
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
- •History of, or active, iritis or uveitis in either eye
- •Pre-existing retinal diseases in either eye that may pre-dispose the 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
Binocular Distance Corrected Near Visual Acuity (DCNVA)
时间窗: Day 28
Proportion of treatment responders \[subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)\] 1 hour post-dose at the Day 28 visit.
次要结局
- Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit.(Day 28)