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Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00519753
First received: August 21, 2007
Last updated: April 17, 2012
Last verified: January 2010
History of Changes
  Purpose

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

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

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in intraocular pressure at 12 weeks from other prior therapies (baseline) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 522
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519753

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00519753     History of Changes
Other Study ID Numbers: CMS-06-12
Study First Received: August 21, 2007
Last Updated: April 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye 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 May 21, 2013