Study of Patient Use and Perception of the Travatan Dosing Aid

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Wills Eye
ClinicalTrials.gov Identifier:
NCT00626067
First received: January 22, 2008
Last updated: February 29, 2008
Last verified: January 2008

January 22, 2008
February 29, 2008
September 2006
February 2007   (final data collection date for primary outcome measure)
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626067 on ClinicalTrials.gov Archive Site
Pilot study of the impact of physician monitoring of compliance on patient compliance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Patient Use and Perception of the Travatan Dosing Aid
Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)

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.

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 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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Glaucoma
  • Device: Fully Functional Travatan Compliance Monitoring Dispenser
    Pt received fully functional monitoring dispenser for use with their Travatan eye drops
  • Device: Partially Functioning Travatan Compliance Monitoring Dispenser
    Patient received a particually functional Travatan Compliance Monitoring Dispenser
  • Device: Non Functioning Travatan Compliance Monitoring Dispenser
    Patient received a non functioning Travatan Compliance Monitoring Dispenser
  • Active Comparator: 1
    Fully functional monitoring device
    Intervention: Device: Fully Functional Travatan Compliance Monitoring Dispenser
  • Active Comparator: 2
    Partially functional monitoring device
    Intervention: Device: Partially Functioning Travatan Compliance Monitoring Dispenser
  • Sham Comparator: 3
    Non-functional monitoring device
    Intervention: Device: Non Functioning Travatan Compliance Monitoring Dispenser
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2007
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to prostaglandin
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00626067
IRB #06-762E, CMS-06-09
No
Jonathan S. Myers, MD, Wills Eye Glaucoma Service
Wills Eye
Alcon Laboratories
Principal Investigator: Jonathan S. Myers, MD Wills Eye Institute
Wills Eye
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP