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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01336569
First received: April 14, 2011
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Glaucoma
Drug: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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%)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy) [ Time Frame: Baseline, up to 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01336569     History of Changes
Other Study ID Numbers: SMA-09-26
Study First Received: April 14, 2011
Results First Received: May 17, 2013
Last Updated: May 17, 2013
Health Authority: Brazil: National Health Surveillance Agency
Brazil: Ethics Committee

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

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