Study of Patient Use and Perception of the Travatan Dosing Aid
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Device: Fully Functional Travatan Compliance Monitoring Dispenser Device: Partially Functioning Travatan Compliance Monitoring Dispenser Device: Non Functioning Travatan Compliance Monitoring Dispenser |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid) |
- Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Pilot study of the impact of physician monitoring of compliance on patient compliance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | September 2006 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Fully functional monitoring device
|
Device: Fully Functional Travatan Compliance Monitoring Dispenser
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
|
|
Active Comparator: 2
Partially functional monitoring device
|
Device: Partially Functioning Travatan Compliance Monitoring Dispenser
Patient received a particually functional Travatan Compliance Monitoring Dispenser
|
|
Sham Comparator: 3
Non-functional monitoring device
|
Device: Non Functioning Travatan Compliance Monitoring Dispenser
Patient received a non functioning Travatan Compliance Monitoring Dispenser
|
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):
- 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 compliance are then 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Open angle glaucoma or ocular hypertension
- Presently using Travatan eye drops
Exclusion Criteria:
- Allergy to prostaglandin
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Jonathan S. Myers, MD, Wills Eye Glaucoma Service |
| ClinicalTrials.gov Identifier: | NCT00626067 History of Changes |
| Other Study ID Numbers: | IRB #06-762E, CMS-06-09 |
| Study First Received: | January 22, 2008 |
| Last Updated: | February 29, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wills Eye:
|
Travatan Dosing Aid compliance monitoring dispenser |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases Travoprost |
Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013