Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-30 @ 12:36 PM
Study NCT ID:
NCT00626067
Status:
COMPLETED
Last Update Posted:
2016-11-10
First Post:
2008-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Patient Use and Perception of the Travatan Dosing Aid
Sponsor:
Wills Eye
Organization:
Study Overview
Official Title:
Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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):
1. Fully functional Travatan compliance monitor
2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
2. 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.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
1. Fully functional Travatan compliance monitor
2. Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
3. Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.
At end of study, patients fill out questionnaire assessing
1. Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
2. 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.
The design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. The use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. As patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. However, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CMS-06-09 | OTHER | Wills Eye Hospital | View |