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Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost APS 40 micrograms/ml eye drop solution
Latanoprost 50 micrograms/ml eye drop solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open Angle Glaucoma, Ocular hypertension, OAG, OH

Eligibility Criteria

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

Inclusion Criteria:

  • Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
  • Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
  • Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.

  • Women of childbearing potential must meet all of the following conditions at Visit 1:

    • They are not breast-feeding.
    • They have a negative urine pregnancy test at Visit 1.
    • They agree to undertake a urine pregnancy test upon entering and exiting the study.
    • They are not planning to become pregnant during the course of the study.
    • They are currently using, and agree to use adequate birth control methods for the duration of the study.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Any abnormality preventing reliable applanation tonometry in the study eye(s).
  • Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
  • Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
  • Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
  • Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
  • Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
  • Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1.
  • Use of ocular medications other than XALATAN® within 7 days of Visit 1.
  • Use of corticosteroids within 30 days of Visit 1.
  • Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
  • History of intolerance or hypersensitivity to any component of the test articles.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • History or evidence of corneal transplant or transplant variant procedures.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Travoprost APS

    XALATAN

    Arm Description

    Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days

    Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days

    Outcomes

    Primary Outcome Measures

    Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)

    Secondary Outcome Measures

    Full Information

    First Posted
    May 4, 2009
    Last Updated
    July 11, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00892762
    Brief Title
    Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (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 is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients 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
    Open Angle Glaucoma, Ocular Hypertension
    Keywords
    Open Angle Glaucoma, Ocular hypertension, OAG, OH

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    434 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Travoprost APS
    Arm Type
    Experimental
    Arm Description
    Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
    Arm Title
    XALATAN
    Arm Type
    Active Comparator
    Arm Description
    Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost APS 40 micrograms/ml eye drop solution
    Intervention Description
    non-BAK (benzalkonium chloride) medication
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost 50 micrograms/ml eye drop solution
    Other Intervention Name(s)
    XALATAN®
    Intervention Description
    BAK-preserved medication
    Primary Outcome Measure Information:
    Title
    Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
    Time Frame
    Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye. Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study. Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1. Women of childbearing potential must meet all of the following conditions at Visit 1: They are not breast-feeding. They have a negative urine pregnancy test at Visit 1. They agree to undertake a urine pregnancy test upon entering and exiting the study. They are not planning to become pregnant during the course of the study. They are currently using, and agree to use adequate birth control methods for the duration of the study. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Any abnormality preventing reliable applanation tonometry in the study eye(s). Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study. Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids. Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1. Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1. Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye. Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1. Use of ocular medications other than XALATAN® within 7 days of Visit 1. Use of corticosteroids within 30 days of Visit 1. Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study. History of intolerance or hypersensitivity to any component of the test articles. Participation in an investigational drug or device study within 30 days of entering this study. History or evidence of corneal transplant or transplant variant procedures. Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Theresa Landry, Ph.D.
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health

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