Adherence Improvement in Glaucoma Patients

• Sponsor: Maastricht University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00603005
• Collaborator: Alcon Research (Industry)
• Enrollment: 802
• Locations: 14
• Arms: 4
• Duration (Months): 27
• Patients Per Site: 57.3
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: Use of TravAlert dosing aid with or without drop guider	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 802 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Supportive Care
• Official Title: Adherence Improvement in Glaucoma Patients
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Device: Use of TravAlert dosing aid with or without drop guider; Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 2	Device: Use of TravAlert dosing aid with or without drop guider; Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 3	Device: Use of TravAlert dosing aid with or without drop guider; Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 4	Device: Use of TravAlert dosing aid with or without drop guider; Each patient will use a dosing aid and/or drop guider for 6 months

Outcome Measures

Primary Outcome Measures

1. Intraocular pressure [6 months]

Secondary Outcome Measures

1. Information with regard to the use of eye drops from data generated by the TravAlert dosing system [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medisch centrum Alkmaar	Alkmaar		Netherlands
2	Wilhelmina ziekenhuis	Assen		Netherlands
3	Amphia ziekenhuis	Breda		Netherlands
4	Jeroen Bosch ziekenhuis	den Bosch		Netherlands
5	Deventer ziekenhuis	Deventer		Netherlands
6	Catharina ziekenhuis	Eindhoven		Netherlands
7	Groene hart ziekenhuis	Gouda		Netherlands
8	ziekenhuis de Tjongerschans	Heerenveen		Netherlands
9	Atrium medisch centrum	Heerlen		Netherlands
10	Westfries gasthuis	Hoorn		Netherlands
11	University hospital	Maastricht		Netherlands
12	Canisius Wilhelmina ziekenhuis	Nijmegen		Netherlands
13	Erasmus medisch centrum	Rotterdam		Netherlands
14	Isala klinieken	Zwolle		Netherlands

Sponsors and Collaborators

• Maastricht University Medical Center
• Alcon Research

Investigators

• Principal Investigator: Helena J Beckers, MD/phD, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00603005
• Other Study ID Numbers: MEC 07-1-015; CTCM-071015
• First Posted: Jan 28, 2008
• Last Update Posted: Feb 24, 2010
• Last Verified: Feb 1, 2010

• Keywords provided by , ,: Glaucoma; Adherence
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Feb 24, 2010