Adherence Improvement in Glaucoma Patients | NCT00603005

Studies
Adherence Improvement in Glaucoma Patients

NCT00603005

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Feb 24, 2010Estimated

Enrollment

802Actual

Phase

Not Applicable

Conditions

Glaucoma

Interventions

Use of TravAlert dosing aid with or without drop guider

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CTCM-071015

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Jan 2010Actual

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 26, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2010

Last Update Posted Date

Feb 24, 2010Estimated

Name	Class
Alcon Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

802Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Device: Use of TravAlert dosing aid with or without drop guider
2	Experimental	Device: Use of TravAlert dosing aid with or without drop guider
3	Experimental	Device: Use of TravAlert dosing aid with or without drop guider
4	Experimental	Device: Use of TravAlert dosing aid with or without drop guider

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Use of TravAlert dosing aid with or without drop guider	Device	Each patient will use a dosing aid and/or drop guider for 6 months	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraocular pressure		6 months

Secondary Outcomes

Measure	Description	Time Frame
Information with regard to the use of eye drops from data generated by the TravAlert dosing system		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis glaucoma or ocular hypertension
Treatment with travoprost or travoprost/timolol

Exclusion Criteria:

High risk of side effects expected from travoprost or travoprost/timolol
Absolute inability to administer eye drops
Difficulty in reading or speaking Dutch

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helena J Beckers, MD/phD	Maastricht University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jeroen Bosch ziekenhuis		's-Hertogenbosch			Netherlands
Medisch centrum Alkmaar

Condition Browse Module

MeSH Terms

ID	Term
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided