Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
研究概览
简要总结
The primary objective of this study is to determine the opinions of patients who are given the Travatan Compliance Monitoring Dispenser to use to dispense their Travatan glaucoma drops.
详细描述
Patients enrolled in this study will use the new Travatan compliance monitoring dispenser for 6 weeks. Patients will be informed that some, but not all, patients' compliance will be monitored by the device. Patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio):
- Fully functional Travatan compliance monitor
- Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
- Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
- Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
- patient's belief as to whether their compliance was monitored or not
Rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open angle glaucoma or ocular hypertension
- •Presently using Travatan eye drops
排除标准
- •Allergy to prostaglandin
结局指标
主要结局
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
时间窗: 6 weeks
次要结局
- Pilot study of the impact of physician monitoring of compliance on patient compliance(6 weeks)
研究者
Jonathon Myers
Attending Surgeon
Wills Eye