NCT00626067

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

January 22, 2008

Last Update Submit

November 8, 2016

Conditions

Glaucoma

Keywords

Travatan Dosing Aidcompliance monitoring dispenser

Outcome Measures

Primary Outcomes (1)

  • Assess patients' opinions regarding new Travatan Compliance Monitoring Dispenser

    6 weeks

Secondary Outcomes (1)

  • Pilot study of the impact of physician monitoring of compliance on patient compliance

    6 weeks

Study Arms (3)

1 Fully functional monitoring device

ACTIVE COMPARATOR

Fully functional monitoring device

Device: Fully functional monitoring device

2 Partially functional monitoring device

ACTIVE COMPARATOR

Partially functional monitoring device

Device: Partially functional monitoring device

3 Non-functional monitoring device

SHAM COMPARATOR

Non-functional monitoring device

Device: Non-functional monitoring device

Interventions

Fully functional monitoring deviceDEVICE

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

1 Fully functional monitoring device
Partially functional monitoring deviceDEVICE

Patient received a particually functional Travatan Compliance Monitoring Dispenser

2 Partially functional monitoring device
Non-functional monitoring deviceDEVICE

Patient received a non functioning Travatan Compliance Monitoring Dispenser

3 Non-functional monitoring device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Allergy to prostaglandin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jonathan S. Myers, MD

    Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Surgeon

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 29, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 10, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

A Manuscript has been accepted and published in Patient Preference and Adherence.