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Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost ophthalmic solution 0.005% (XALATAN®)
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

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older.
  • Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
  • Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
  • Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
  • Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
  • Best corrected visual acuity of -0.6 logMAR or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
  • Use of contact lenses within 30 days of Visit 1.
  • Use of contact lenses during the study.
  • Participation in an investigational drug or device study within 30 days of entering this study.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Travoprost

    Latanoprost

    Arm Description

    One drop self-administered in the study eye(s) once daily for 90 days

    One drop self-administered in the study eye(s) once daily for 90 days

    Outcomes

    Primary Outcome Measures

    Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
    The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.

    Secondary Outcome Measures

    Percentage of Patients With Corneal Fluorescein Staining Score = 0
    The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.

    Full Information

    First Posted
    September 25, 2008
    Last Updated
    April 20, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00761319
    Brief Title
    Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health
    Official Title
    An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    September 2009 (Actual)
    Study Completion Date
    September 2009 (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 the study is to compare two ophthalmic solutions 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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Travoprost
    Arm Type
    Experimental
    Arm Description
    One drop self-administered in the study eye(s) once daily for 90 days
    Arm Title
    Latanoprost
    Arm Type
    Active Comparator
    Arm Description
    One drop self-administered in the study eye(s) once daily for 90 days
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
    Other Intervention Name(s)
    TRAVATAN Z®
    Intervention Description
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost.
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost ophthalmic solution 0.005% (XALATAN®)
    Other Intervention Name(s)
    XALATAN®
    Intervention Description
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.
    Primary Outcome Measure Information:
    Title
    Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
    Description
    The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. A negative number represents a perceived improvement in ocular health.
    Time Frame
    Day 0, Day 90
    Secondary Outcome Measure Information:
    Title
    Percentage of Patients With Corneal Fluorescein Staining Score = 0
    Description
    The corneal surface was assessed by the investigator and graded on a scale of 0-3, where 0 = Absent (no staining present) and 3 = Severe (>50% coverage). Percentage of patients with score = 0 at 90 days was calculated by dividing the number of patients with score = 0 by tht total number of patients analyzed.
    Time Frame
    Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years or older. Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol. Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1. Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears. Best corrected visual acuity of -0.6 logMAR or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article. Use of contact lenses within 30 days of Visit 1. Use of contact lenses during the study. Participation in an investigational drug or device study within 30 days of entering this study. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

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    Phase III Clinical Trial of TRAVATAN Z in Ocular Surface Health

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