Comparison of Pilocarpine, Brimonidine, Oxymetazoline, Hialuronic Acid, Bromfenac Ophthalmic Compound With Pilocarpine and Brimonidine to Improve Uncorrected Visual Acuity in Healthy Presbyopic Individuals
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
- Eyes improving 3 lines or more near visual acuity
研究概览
简要总结
Safety and Efficacy of Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (PBOHB) ophthalmic compound compared to Pilocarpine and Brimonidine 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 compared to Pilocarpine and Brimonidine one hour after binocular instillation.
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
- Double (Participant, Care Provider)
盲法说明
While in office the care provider took a number out of a closed container. Number 1 was designated for the Brimonidine, Number 2 was designated for the PBOHB compound, Number 3 was designated for de Pilocarpine compound
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 - 59 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
Experimental PBOHB
Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
干预措施: Pilocarpine Hydrochloride (Drug)
Experimental PBOHB
Pilocarpine, brimonidine, Oxymetazoline combined with Hyaluronic Acid and Bromfenac combined in an ophthalmic solution to be randomly instilled in one eye.
干预措施: Brimonidine Tartrate (Drug)
Pilocarpine 5 mgs
Pilocarpine was instilled in the other oye.
干预措施: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (Drug)
Brimonidine 0.5 mgs
Brimonidine was instilled in the other eye.
干预措施: Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac (Drug)
结局指标
主要结局
Eyes improving 3 lines or more near visual acuity
时间窗: 1 hour
Eyes instilled with Pilocarpine
Number of eyes improving 3 lines or more near visual acuity
时间窗: 1 hour
Eyes instilled with PBOHB
Eyes improving 3 lines or more near VA
时间窗: 1 hour
Eyes instilled with Brimonidine
次要结局
未报告次要终点
研究者
Cesar Alejandro Sanchez Galeana
Principal Investigator
Optall Vision