The Effects of the Water Drinking Test on Intraocular Pressure of Glaucoma Patients Undergoing 24 Hour Continuous Monitoring With the SENSIMED Triggerfish
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- 24-hour IOP Patterns
研究概览
简要总结
This clinical trial is designed to investigate the efficacy profile of the SENSIMED Triggerfish® during 24-hour IOP monitoring in patients with glaucoma or ocular hypertension, done three times at monthly intervals under different therapeutic regimen. This trial will also evaluate the efficacy of SENSIMED Triggerfish® to detect changes in intraocular pressure (IOP) after the water drinking test (WDT) will be investigated.
详细描述
The investigation will recruit male and female patients 18-80 years old and diagnosed with glaucoma or ocular hypertension requiring hypotensive ocular treatment. Up to 100 subjects will be enrolled in the study to ensure a minimum of 80 completing three IOP fluctuation monitoring sessions. Patients will be considered enrolled in the study upon signature of informed consent. A screening visit and three 26-hour IOP fluctuation monitoring sessions are planned for each patient. IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days). All subjects will be monitored during the same period of the day (± 1hr). The expected duration of participation for each patient is of 3.5 days over three to four months. Patients will be recruited over a 16-month period. The total expected study duration is 16 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to comply with the study procedures
- •18-80 years old
- •Subjects diagnosed with glaucoma, based on presence of repeatable visual field loss and/or glaucomatous optic neuropathy based on masked review of optic disc stereophotographs and under ocular hypotensive treatment, or diagnosed with ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under ocular hypotensive treatment.
- •Subject has consented to be in the trial
- •Visual acuity of 20/80 or better
- •Ability to understand the character and individual consequences of the study
- •For women of childbearing potential, adequate contraception
- •Stable anti-hypertensive treatment regimen 4 weeks prior to the screening visit and throughout the study.
- •Exclusion criteria
- •Subjects with chronic kidney failure and chronic hear disease
- •Subjects with contraindications for wearing contact lenses
- •Severe dry eye syndrome
- •Keratoconus or other corneal abnormality
- •Conjunctival or intraocular inflammation
- •Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery and laser a minimum of 3 months prior to the screening visit.
- •Full frame metal glasses during SENSIMED Triggerfish® monitoring
- •Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
- •Pregnancy and lactation
- •Simultaneous participation in other clinical studies
- •No patient will be allowed to participate in this trial more than once
排除标准
- 未提供
研究组 & 干预措施
Prostaglandin Analogue
WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (PGA + BB)
干预措施: SENSIMED Triggerfish (Device)
Carbonic Anhydrase Inhibitor
WDT protocol Visit 1 - (WDT after washout) 20 Visit 2 - (WDT with treatment) 20 Visit 3 - (WDT with PGA or BB add-on) 20 (CAI+ BB)
干预措施: SENSIMED Triggerfish (Device)
结局指标
主要结局
24-hour IOP Patterns
时间窗: 24-hour
Assess IOP patterns between day and night time and changes after the WDT.
Intraocular Pressure
时间窗: 24-hours
IOP monitoring sessions will be carried out in ambulatory mode at 4 week intervals (plus/minus 7 days)
次要结局
- Ocular Adverse Events(24-hours)