Skip to content

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00626067
Enrollment
45
Registered
2008-02-29
Start date
2006-09-30
Completion date
2007-02-28
Last updated
2016-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Travatan Dosing Aid, compliance monitoring dispenser

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.

Interventions

DEVICEFully functional monitoring device

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

DEVICEPartially functional monitoring device

Patient received a particually functional Travatan Compliance Monitoring Dispenser

DEVICENon-functional monitoring device

Patient received a non functioning Travatan Compliance Monitoring Dispenser

Sponsors

Alcon Research
CollaboratorINDUSTRY
Wills Eye
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Allergy to prostaglandin

Design outcomes

Primary

MeasureTime frame
Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser6 weeks

Secondary

MeasureTime frame
Pilot study of the impact of physician monitoring of compliance on patient compliance6 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026