Study of Patient Use and Perception of the Travatan Dosing Aid
NCT ID: NCT00626067
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
45 participants
INTERVENTIONAL
2006-09-30
2007-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
DOUBLE
Study Groups
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1 Fully functional monitoring device
Fully functional monitoring device
Fully functional monitoring device
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
2 Partially functional monitoring device
Partially functional monitoring device
Partially functional monitoring device
Patient received a particually functional Travatan Compliance Monitoring Dispenser
3 Non-functional monitoring device
Non-functional monitoring device
Non-functional monitoring device
Patient received a non functioning Travatan Compliance Monitoring Dispenser
Interventions
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Fully functional monitoring device
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
Partially functional monitoring device
Patient received a particually functional Travatan Compliance Monitoring Dispenser
Non-functional monitoring device
Patient received a non functioning Travatan Compliance Monitoring Dispenser
Eligibility Criteria
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Inclusion Criteria
* Presently using Travatan eye drops
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Wills Eye
OTHER
Responsible Party
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Jonathon Myers
Attending Surgeon
Principal Investigators
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Jonathan S. Myers, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Institute
Related Links
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Patient Preference and Adherence
Other Identifiers
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CMS-06-09
Identifier Type: OTHER
Identifier Source: secondary_id
IRB #06-762E
Identifier Type: -
Identifier Source: org_study_id