Study of Patient Use and Perception of the Travatan Dosing Aid

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Device: Non-functional monitoring device; Device: Fully functional monitoring device; Device: Partially functional monitoring device

• Registration Number: NCT00626067
• Lead Sponsor: Wills Eye

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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-29
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Open angle glaucoma or ocular hypertension
• Presently using Travatan eye drops

Exclusion Criteria

• Allergy to prostaglandin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3 Non-functional monitoring device	Non-functional monitoring device	Non-functional monitoring device
1 Fully functional monitoring device	Fully functional monitoring device	Fully functional monitoring device
2 Partially functional monitoring device	Partially functional monitoring device	Partially functional monitoring device

Primary Outcome Measures

Name	Time	Method
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser	6 weeks

Secondary Outcome Measures

Name	Time	Method
Pilot study of the impact of physician monitoring of compliance on patient compliance	6 weeks