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

This study has been completed.
Information provided by (Responsible Party):
Alcon Research Identifier:
First received: June 24, 2009
Last updated: July 16, 2014
Last verified: July 2014
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 Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
Drug: Travoprost/Timolol Maleate Fixed Combination solution
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Adverse Events (AEs) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00928590

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

Responsible Party: Alcon Research Identifier: NCT00928590     History of Changes
Other Study ID Numbers: C-09-032  EudraCT Number 2009-013178-42 
Study First Received: June 24, 2009
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Germany: Ethics Commission
Belgium: Institutional Review Board
Latvia: Institutional Review Board
Australia: Human Research Ethics Committee

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

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 26, 2016