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
  Purpose

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.


Condition Intervention Phase
Glaucoma
Device: Fully Functional Travatan Compliance Monitoring Dispenser
Device: Partially Functioning Travatan Compliance Monitoring Dispenser
Device: Non Functioning Travatan Compliance Monitoring Dispenser
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pilot study of the impact of physician monitoring of compliance on patient compliance [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: September 2006
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Fully functional monitoring device
Device: Fully Functional Travatan Compliance Monitoring Dispenser
Pt received fully functional monitoring dispenser for use with their Travatan eye drops
Active Comparator: 2
Partially functional monitoring device
Device: Partially Functioning Travatan Compliance Monitoring Dispenser
Patient received a particually functional Travatan Compliance Monitoring Dispenser
Sham Comparator: 3
Non-functional monitoring device
Device: Non Functioning Travatan Compliance Monitoring Dispenser
Patient received a non functioning Travatan Compliance Monitoring Dispenser

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to prostaglandin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626067

Sponsors and Collaborators
Wills Eye
Alcon Laboratories
Investigators
Principal Investigator: Jonathan S. Myers, MD Wills Eye Institute
  More Information

No publications provided

Responsible Party: Jonathan S. Myers, MD, Wills Eye Glaucoma Service
ClinicalTrials.gov Identifier: NCT00626067     History of Changes
Other Study ID Numbers: IRB #06-762E, CMS-06-09
Study First Received: January 22, 2008
Last Updated: February 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Wills Eye:
Travatan Dosing Aid
compliance monitoring dispenser

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Travoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014