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Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to 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.
ClinicalTrials.gov Identifier: NCT00519753
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany
Study Start Date : August 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: DuoTrav
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks
Other Name: DUOTRAV®



Primary Outcome Measures :
  1. Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline) [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Change in intraocular pressure at 12 weeks from other prior therapies (baseline) [ Time Frame: 12 weeks ]


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

Inclusion Criteria:

  • Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Age related.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00519753


Locations
Germany
Mainz
Mainz, Germany, DE-55101
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Mark C Jasek Alcon Research

Publications of Results:
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00519753     History of Changes
Other Study ID Numbers: CMS-06-12
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: January 2010

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Timolol
Travoprost
Maleic acid
Cloprostenol
Pharmaceutical Solutions
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