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OpenTrials
Completed

NCT Number: NCT00626067

Study of Patient Use and Perception of the 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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):

  • Fully functional Travatan compliance monitor
  • Travatan compliance monitor with LCD display and alarms disabled, but compliance monitoring intact
  • Travatan compliance monitor with LCD display, alarms and compliance monitor disabled.

At end of study, patients fill out questionnaire assessing

  • Patient opinion regarding device: ease of use of new device; preference vs Travatan use without device, etc
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Allergy to prostaglandin

Treatment and study plan

Fully functional monitoring device

Device

Pt received fully functional monitoring dispenser for use with their Travatan eye drops

Partially functional monitoring device

Device

Patient received a particually functional Travatan Compliance Monitoring Dispenser

Non-functional monitoring device

Device

Patient received a non functioning Travatan Compliance Monitoring Dispenser

Primary outcomes

  1. Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser

    Time frame: 6 weeks

Secondary outcomes

  1. Pilot study of the impact of physician monitoring of compliance on patient compliance

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Collaborators

  • Alcon Research

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Feb 29, 2008
Registry last updated
Nov 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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