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Clinical Trials/NCT00626067
NCT00626067
Completed
Phase 4

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

Wills Eye0 sites45 target enrollmentSeptember 2006
ConditionsGlaucoma

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Wills Eye
Enrollment
45
Primary Endpoint
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
February 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Wills Eye
Responsible Party
Principal Investigator
Principal Investigator

Jonathon Myers

Attending Surgeon

Wills Eye

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Allergy to prostaglandin

Outcomes

Primary Outcomes

Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser

Time Frame: 6 weeks

Secondary Outcomes

  • Pilot study of the impact of physician monitoring of compliance on patient compliance(6 weeks)

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