Pilocarpine, Brimonidine, Oxymetazoline Ophthalmic Compound Safety and Efficacy in Patients With Presbyopia
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Jaeger near uncorrected visual acuity improvement
研究概览
简要总结
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound to improve uncorrected near vision in healthy presbyopic patients one hour after instillation.
详细描述
To determine the safety and efficacy of a novel pharmacological compound of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) to improve uncorrected near vision in healthy presbyopic patients one hour after binocular instillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presbyopic
- •40 - 60 years
排除标准
- •Diabetics
- •Previous eye surgery
- •Previous eye disease
- •> 0.50 myopia
- •> 1.5 hyperopia or astigmatism
研究组 & 干预措施
PBOHB
Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic Acid, Bromfenac to evaluate safety and efficacy to improve uncorrected near vision in healthy presbyopic patients
干预措施: Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound (Drug)
结局指标
主要结局
Jaeger near uncorrected visual acuity improvement
时间窗: 1 hour
Measure uncorrected near vision change after binocular instillation of PBOHB compound
次要结局
未报告次要终点
研究者
Cesar Alejandro Sanchez Galeana
Principal Investigator
Optall Vision