Glaucoma Adherence Study

Completed

• Conditions: Ocular Hypertension; Primary Open Angle Glaucoma
• Interventions: Drug: Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav); Device: Travalert Dosing Aid

• Registration Number: NCT00676637
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is evaluate adherence to DuoTrav® when reinforced by the use of the Travalert™ Dosing Aid.

Detailed Description

This study was conducted in France, UK, Italy, and Netherlands. An identical study was conducted in Spain under Protocol ID EMD-07-02. A combined enrollment number is presented.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-12
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-29
• Last Update Posted: 2012-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Travalert with DuoTrav	Travoprost 0.004%/timolol 0.05% fixed combination eye drops (DuoTrav)	One drop in study eye(s) once daily in the evening for four months
Travalert with DuoTrav	Travalert Dosing Aid	One drop in study eye(s) once daily in the evening for four months

Primary Outcome Measures

Name	Time	Method
Mean Change from Baseline in Intraocular Pressure at 4 months	Baseline, 4 months	As measured by Goldmann applanation tonometry

Trial Locations

Locations (4)

Milan; 🇮🇹 Milan, Italy

France; 🇫🇷 Paris, France

London; 🇬🇧 London, United Kingdom

Maastricht; 🇳🇱 Maastricht, Netherlands