Efficacy of the Nanodropper Device on Intraocular Pressure in Patients With Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP) at Baseline
研究概览
简要总结
Glaucoma is the leading cause of irreversible blindness worldwide. Previous studies demonstrate that smaller eye drops used in the treatment of glaucoma are just as efficacious as their larger counterparts. The proposed study hopes to demonstrate the non-inferiority of using Nanodropper to lower intraoccular pressure (IOP) in glaucoma patients compared to standard of care eye drops.
详细描述
The proposed study strives to demonstrate the non-inferiority of using Nanodropper to lower IOP in glaucoma patients compared to standard of care (SOC) eye drops in a randomized trial.
Primary Aim: Demonstrate non-inferiority of using Nanodropper to lower IOP compared to standard of care eye drops in glaucoma patients.
Stable glaucoma participants and ocular hypertension participants of ages 18+ will be randomized to either use Nanodropper for eye drop administration in both eyes OR administer drops regularly (standard of care) in both eyes. Participants will be followed-up at 1 month and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Study personnel who will evaluate the IOP and economic endpoints will be blinded to patients' assigned dispenser types for the duration of the study.
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
- •18 years old or older
- •Diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT)
- •Use of prostaglandin analogue (PGA) eye drop
- •Stable disease status (no visual field loss progression or increase in IOP-lowering medications in the last 6 months)
排除标准
- •Uncontrolled glaucoma
- •Have had eye surgery (including laser procedures) within the past six months
- •Have a diagnosis of acute angle-closure glaucoma and/or other retinal diseases
- •Use of non-PGA class of IOP-lowering medication
研究组 & 干预措施
Nanodropper
Participants will receive the Nanodropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the Nanodropper.
干预措施: Nanodropper (Device)
Standard of Care Dropper
Participants will receive standard of care eye dropper with instructions and attend clinic visits at baseline, 1, and 3 months. Participants will administer their eye drops using the standard of care eye dropper.
结局指标
主要结局
Intraocular Pressure (IOP) at Baseline
时间窗: At Baseline
IOP measurement of the eye will be collected at the baseline visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular Pressure (IOP) at Month 1
时间窗: 1 month
IOP measurement of the eye will be collected at the Month 1 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
Intraocular Pressure (IOP) at Month 3
时间窗: 3 months
IOP measurement of the eye will be collected at the month 3 visit using routine methods including Goldman applanation tonometry and pneumotonometer.
次要结局
- Survey(3 months)
- Conjunctival Grading at Baseline(At baseline)
- Conjunctival Grading at Month 3(3 months)