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Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol

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ClinicalTrials.gov Identifier: NCT01336569
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : July 8, 2013
Last Update Posted : July 8, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)
Study Start Date : February 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012


Arm Intervention/treatment
Experimental: DuoTrav
Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Other Name: DuoTrav



Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) [ Time Frame: Baseline, up to 6 weeks ]
    As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.



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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:

  • Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
  • Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
  • On a stable medication regimen for IOP reduction one week prior to the screening visit;
  • Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
  • Sign informed consent;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
  • Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
  • Infection in either eye;
  • Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
  • Risk for visual field or visual acuity worsening, in the opinion of the investigator;
  • Women of childbearing potential;
  • Pregnant or lactating women;
  • Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
  • Participation in another clinical study within 30 days before the screening visit;
  • 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): NCT01336569


Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abayomi Ogundele, PharmD Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01336569     History of Changes
Other Study ID Numbers: SMA-09-26
First Posted: April 18, 2011    Key Record Dates
Results First Posted: July 8, 2013
Last Update Posted: July 8, 2013
Last Verified: May 2013

Keywords provided by Alcon Research:
Primary Open-Angle Glaucoma
Ocular Hypertension
Pigment Dispersion Glaucoma
IOP

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
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors