Study of Patient Use and Perception of the Travatan Dosing Aid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00626067
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : November 10, 2016
Alcon Research
Information provided by (Responsible Party):
Jonathon Myers, 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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Fully functional monitoring device Device: Partially functional monitoring device Device: Non-functional monitoring device Phase 4

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Patient Acceptance and Impact of the New Travatan™ Compliance Monitoring Dispenser (Travatan™ Dosing Aid)
Study Start Date : September 2006
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

Arm Intervention/treatment
Active Comparator: 1 Fully functional monitoring device
Fully functional monitoring device
Device: Fully functional monitoring device
Pt received fully functional monitoring dispenser for use with their Travatan eye drops

Active Comparator: 2 Partially functional monitoring device
Partially functional monitoring device
Device: Partially functional monitoring device
Patient received a particually functional Travatan Compliance Monitoring Dispenser

Sham Comparator: 3 Non-functional monitoring device
Non-functional monitoring device
Device: Non-functional monitoring device
Patient received a non functioning Travatan Compliance Monitoring Dispenser

Primary Outcome Measures :
  1. Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Pilot study of the impact of physician monitoring of compliance on patient compliance [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to prostaglandin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00626067

Sponsors and Collaborators
Wills Eye
Alcon Research
Principal Investigator: Jonathan S. Myers, MD Wills Eye Institute

Additional Information:
Responsible Party: Jonathon Myers, Attending Surgeon, Wills Eye Identifier: NCT00626067     History of Changes
Other Study ID Numbers: IRB #06-762E
CMS-06-09 ( Other Identifier: Wills Eye Hospital )
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A Manuscript has been accepted and published in Patient Preference and Adherence.

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

Additional relevant MeSH terms:
Antihypertensive Agents