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Effects of Travatan Z and Xalatan on Ocular Surface Health

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
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 Glaucoma focused on measuring Ocular surface health, OSDI, TFBUT, Glaucoma, Ocular hypertension, Corneal staining

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older.
  • Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
  • Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
  • IOP controllable and stable on the study medication alone (both eyes).
  • Believed to have ocular surface disease (OSD).
  • Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
  • Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
  • Current use of punctual plugs.
  • Women of childbearing potential not using reliable means of birth control.
  • Women who are pregnant or lactating.
  • Suspected or diagnosed with Sjogrens's syndrome.
  • Current use of any brand of artificial tears containing BAK.
  • Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
  • Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
  • Current use of contact lenses within 30 days of Visit 1.
  • Participation in any other investigational study within 30 days prior to Visit 1.
  • 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 at night for 12 weeks

    One drop self-administered in the study eye(s) once daily at night for 12 weeks

    Outcomes

    Primary Outcome Measures

    Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
    Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.

    Secondary Outcome Measures

    Mean Change at 12 Weeks (Day 84) 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. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.

    Full Information

    First Posted
    June 30, 2008
    Last Updated
    March 30, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00708422
    Brief Title
    Effects of Travatan Z and Xalatan on Ocular Surface Health
    Official Title
    Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 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 this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    Ocular surface health, OSDI, TFBUT, Glaucoma, Ocular hypertension, Corneal staining

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    231 (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 at night for 12 weeks
    Arm Title
    Latanoprost
    Arm Type
    Active Comparator
    Arm Description
    One drop self-administered in the study eye(s) once daily at night for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
    Other Intervention Name(s)
    TRAVATAN Z®, travoprost
    Intervention Description
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
    Intervention Type
    Drug
    Intervention Name(s)
    Latanoprost ophthalmic solution 0.005% (XALATAN®)
    Other Intervention Name(s)
    XALATAN®, latanoprost
    Intervention Description
    Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.
    Primary Outcome Measure Information:
    Title
    Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
    Description
    Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
    Time Frame
    12 weeks (Day 84)
    Secondary Outcome Measure Information:
    Title
    Mean Change at 12 Weeks (Day 84) 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. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
    Time Frame
    12 weeks (Day 84)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years of age or older. Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye). Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1. IOP controllable and stable on the study medication alone (both eyes). Believed to have ocular surface disease (OSD). Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye. Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs. Current use of punctual plugs. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Suspected or diagnosed with Sjogrens's syndrome. Current use of any brand of artificial tears containing BAK. Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study. Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1. Current use of contact lenses within 30 days of Visit 1. Participation in any other investigational study within 30 days prior to Visit 1. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Judy Vittitoe, RN, MPH
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Effects of Travatan Z and Xalatan on Ocular Surface Health

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