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Efficacy Study of Travoprost APS Versus TRAVATAN

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
Travoprost 0.004% (BAK-preserved) Eye Drops, 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 OAG, OHT

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age or older, either gender and any race.
  • Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
  • Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.

  • All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

    ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential not meeting conditions set in the protocol.
  • Severe central visual field loss.
  • Angle Shaffer grade < 2.
  • Cup/disc ratio > 0.8 (horizontal or vertical measurement).
  • Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
  • Intraocular surgery or trauma within last 6 months.
  • Any abnormality preventing reliable applanation tonometry.
  • History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
  • Allergy/hypersensitivity to study medications.
  • Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
  • Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
  • Use of any additional topical or systemic ocular hypotensive medication during the study.
  • Therapy with another investigational agent within 30 days prior to the Screening visit.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    TRAVATAN APS

    TRAVATAN

    Arm Description

    One drop once daily in the evening for 3 months

    One drop once daily in the evening for 3 months

    Outcomes

    Primary Outcome Measures

    Mean Intraocular Pressure at 9:00 am
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
    Mean Intraocular Pressure at 11:00 am
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
    Mean Intraocular Pressure at 4:00 pm
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

    Secondary Outcome Measures

    Full Information

    First Posted
    February 19, 2009
    Last Updated
    April 4, 2012
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00848536
    Brief Title
    Efficacy Study of Travoprost APS Versus TRAVATAN
    Official Title
    A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    January 2010 (Actual)
    Study Completion Date
    January 2010 (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
    A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN 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
    OAG, OHT

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    TRAVATAN APS
    Arm Type
    Experimental
    Arm Description
    One drop once daily in the evening for 3 months
    Arm Title
    TRAVATAN
    Arm Type
    Active Comparator
    Arm Description
    One drop once daily in the evening for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution
    Intervention Description
    One drop once daily in the evening for 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
    Intervention Description
    One drop once daily in the evening for 3 months
    Primary Outcome Measure Information:
    Title
    Mean Intraocular Pressure at 9:00 am
    Description
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
    Time Frame
    3 months (measured at 9:00 am)
    Title
    Mean Intraocular Pressure at 11:00 am
    Description
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
    Time Frame
    3 months (measured at 11:00 am)
    Title
    Mean Intraocular Pressure at 4:00 pm
    Description
    For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
    Time Frame
    3 months (measured at 4:00 pm)

    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, either gender and any race. Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT). Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy. All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits): ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential not meeting conditions set in the protocol. Severe central visual field loss. Angle Shaffer grade < 2. Cup/disc ratio > 0.8 (horizontal or vertical measurement). Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal). Intraocular surgery or trauma within last 6 months. Any abnormality preventing reliable applanation tonometry. History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study. Allergy/hypersensitivity to study medications. Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit. Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP. Use of any additional topical or systemic ocular hypotensive medication during the study. Therapy with another investigational agent within 30 days prior to the Screening visit. Other protocol-defined exclusion criteria may apply.

    12. IPD Sharing Statement

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    Efficacy Study of Travoprost APS Versus TRAVATAN

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