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: May 16, 2012
Last verified: May 2012
  Purpose

The purpose of the 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 (POLYQUAD-preserved) solution (DuoTrav APS)
Phase 3

Study Type: Interventional
Study Design: 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 155
Study Start Date: July 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DuoTrav APS
One drop in the study eye(s) once daily, at 9 AM, for 12 months
Drug: Travoprost/Timolol Maleate Fixed Combination (POLYQUAD-preserved) solution (DuoTrav APS)
One drop in the study eye(s) once daily, at 9 AM, for 12 months
Other Name: DuoTrav APS

  Eligibility

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

Inclusion Criteria:

  • Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication in the opinion of the investigator.
  • Patients who are currently on a stable treatment of IOP-lowering medication.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • BCVA not worse than 55 letters
  • Additional clinically relevant ocular or systemic conditions may be excluded.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928590

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
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: May 16, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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 April 17, 2014