Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CMS-06-09 | Other Identifier | Wills Eye Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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):
At end of study, patients fill out questionnaire assessing
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Fully functional monitoring device | Active Comparator | Fully functional monitoring device |
|
| 2 Partially functional monitoring device | Active Comparator | Partially functional monitoring device |
|
| 3 Non-functional monitoring device | Sham Comparator | Non-functional monitoring device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully functional monitoring device | Device | Pt received fully functional monitoring dispenser for use with their Travatan eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pilot study of the impact of physician monitoring of compliance on patient compliance | 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan S. Myers, MD | Wills Eye Institute | Principal Investigator |
Not provided
Not provided
| Label | URL |
|---|---|
| Patient Preference and Adherence | View source |
Not provided
A Manuscript has been accepted and published in Patient Preference and Adherence.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Partially functional monitoring device | Device | Patient received a particually functional Travatan Compliance Monitoring Dispenser |
|
| Non-functional monitoring device | Device | Patient received a non functioning Travatan Compliance Monitoring Dispenser |
|