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

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Travoprost 0.004%/timolol maleate 0.5% fixed combination
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DuoTrav

Arm Description

Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2011
Last Updated
May 17, 2013
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01336569
Brief Title
Safety and Efficacy of Changing to DuoTrav in Patients Uncontrolled on Timolol
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Primary Open-Angle Glaucoma, Ocular Hypertension, Pigment Dispersion Glaucoma, IOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DuoTrav
Arm Type
Experimental
Arm Description
Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Intervention Type
Drug
Intervention Name(s)
Travoprost 0.004%/timolol maleate 0.5% fixed combination
Other Intervention Name(s)
DuoTrav
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
Description
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.
Time Frame
Baseline, up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abayomi Ogundele, PharmD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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

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