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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00928590
First received: June 24, 2009
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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)

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928590

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov 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
pseudoexfoliation
pigment dispersion

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Travoprost
Maleic acid
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

ClinicalTrials.gov processed this record on July 29, 2014