Safety Study of DuoTrav APS in Patients With Open-Angle Glaucoma or Ocular Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00928590
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: Travoprost/Timolol Maleate Fixed Combination solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : July 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: DuoTrav APS
Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
Drug: Travoprost/Timolol Maleate Fixed Combination solution
Other Names:
  • DuoTrav APS
  • DuoTrav (POLYQUAD-preserved)

Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Willing and able to sign an informed consent document.
  • Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
  • Stable treatment of an IOP-lowering medication.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, breastfeeding, or not using adequate birth control.
  • Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00928590

Sponsors and Collaborators
Alcon Research
Study Director: Theresa Landry, Ph.D Alcon Research

Responsible Party: Alcon Research Identifier: NCT00928590     History of Changes
Other Study ID Numbers: C-09-032
EudraCT Number 2009-013178-42
First Posted: June 26, 2009    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014

Keywords provided by Alcon Research:
open-angle glaucoma
ocular hypertension
pigment dispersion

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