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Safety and Efficacy Study of DuoTrav APS Versus DuoTrav

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: NCT00862472
Recruitment Status : Withdrawn (Management decision not to conduct an additional efficacy study.)
First Posted : March 17, 2009
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension Drug: DuoTrav APS Drug: DuoTrav Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Experimental: DuoTrav APS
Drug: DuoTrav APS

Active Comparator: DuoTrav
DuoTrav QD AM
Drug: DuoTrav
DuoTrav QD AM

Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) [ Time Frame: 3 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:

  • Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication

Exclusion Criteria:

  • VA not worse than 0.60
  • additional clinically relevant ocular or systemic conditions may be excluded
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Responsible Party: Alcon Research Identifier: NCT00862472    
Other Study ID Numbers: C-09-006
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Keywords provided by Alcon Research:
open-angle glaucoma
ocular hypertension
open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents