A Phase IIIb Study of DuoTrav to Treat Glaucoma or Ocular Hypertension

Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid

The purpose of this study is to assess patient compliance with DuoTrav versus concomitant administration of Timolol 0.5% plus TRAVATAN in patients with open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution; Drug: Travoprost ophthalmic solution, 0.004%; Drug: Timolol maleate ophthalmic solution, 0.5%

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients with open-angle glaucoma or ocular hypertension;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Visual acuity worse than 0.60;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DuoTrav; One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months, as recorded by dosing aid	Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution; One drop in the study eye(s) once daily at either 8 AM or 8 PM for twelve months using the Dosing Aid; Other Names: DuoTrav
Other: Travatan/Timolol; One drop Timolol in the study eye(s) once daily at 8 AM; one drop of Travatan in the study eye(s) once daily at 8 PM. Both products dosed for twelve months, as recorded by separate dosing aid for each product.	Drug: Travoprost ophthalmic solution, 0.004%; One drop in the study eye(s) once daily at 8 PM for twelve months using the Dosing Aid; Other Names: TRAVATAN; Drug: Timolol maleate ophthalmic solution, 0.5%; One drop in the study eye(s) once daily at 8 AM or twelve months using the Dosing Aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient compliance	Patient compliance will be measured with a dosing aid that records time and date of study drug administration	12 months

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Theresa Landry, Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 23, 2007
• First Submitted That Met QC Criteria: April 24, 2007
• First Posted (Estimate): April 25, 2007

Study Record Updates

• Last Update Posted (Estimate): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Open-angle glaucoma or ocular hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-06-21