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Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

Primary Purpose

Open-angle 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 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.
  • Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
  • Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
  • Best corrected visual acuity of -0.6 logMAR or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Treatment with BAK preserved artificial tears within 30 days of Visit 1.
  • Known or suspected Sjogren's disease.
  • Uncontrolled IOP.
  • History or evidence of infectious or inflammatory ocular conditions.
  • Progressive retinal or optic nerve disease.
  • Ocular laser surgery within 3 months of Visit 1.
  • Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
  • Current use of punctal plugs or punctal cautery.
  • Use of systemic medications that has not been stable for 30 days prior to Visit 1.
  • Use of contact lens within 30 days of 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 (TFBUT)
    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
    November 24, 2008
    Last Updated
    May 25, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00798759
    Brief Title
    Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN
    Official Title
    Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and XALATAN®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 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 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 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    236 (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®
    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®
    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 (TFBUT)
    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
    Day 0, 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
    Day 0, Day 84

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years or older. Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye. Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy. Best corrected visual acuity of -0.6 logMAR or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Treatment with BAK preserved artificial tears within 30 days of Visit 1. Known or suspected Sjogren's disease. Uncontrolled IOP. History or evidence of infectious or inflammatory ocular conditions. Progressive retinal or optic nerve disease. Ocular laser surgery within 3 months of Visit 1. Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1. Current use of punctal plugs or punctal cautery. Use of systemic medications that has not been stable for 30 days prior to Visit 1. Use of contact lens within 30 days of Visit 1. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

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    Examination of Ocular Surface Effects With Administration of Travatan Z and XALATAN

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