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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00465803
First received: April 23, 2007
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost 0.004%/timolol 0.5% ophthalmic solution
Drug: Travoprost ophthalmic solution, 0.004%
Drug: Timolol maleate ophthalmic solution, 0.5%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compliance Study Comparing DuoTrav to TRAVATAN Plus Timolol Using the Dosing Aid

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Patient compliance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Patient compliance will be measured with a dosing aid that records time and date of study drug administration


Enrollment: 81
Study Start Date: March 2007
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: DuoTrav
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 Name: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465803

Locations
United States, Washington
Seattle
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Theresa Landry Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00465803     History of Changes
Other Study ID Numbers: C-06-21
Study First Received: April 23, 2007
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Open-angle glaucoma or ocular hypertension

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Maleic acid
Cloprostenol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on April 17, 2014