Study of Patient Use and Perception of the Travatan Dosing Aid

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Fully functional monitoring device
* Device: Partially functional monitoring device
* Device: Non-functional monitoring device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Open angle glaucoma or ocular hypertension Presently using Travatan eye drops Exclusion Criteria: Allergy to prostaglandin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 Fully functional monitoring device<br>Fully functional monitoring device | Device: Fully functional monitoring device<br>* Pt received fully functional monitoring dispenser for use with their Travatan eye drops<br>|
| Active Comparator: 2 Partially functional monitoring device<br>Partially functional monitoring device | Device: Partially functional monitoring device<br>* Patient received a particually functional Travatan Compliance Monitoring Dispenser<br>|
| Sham Comparator: 3 Non-functional monitoring device<br>Non-functional monitoring device | Device: Non-functional monitoring device<br>* Patient received a non functioning Travatan Compliance Monitoring Dispenser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pilot study of the impact of physician monitoring of compliance on patient compliance |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Travatan Dosing Aid, compliance monitoring dispenser