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6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dose Level A / Brinzolamide 1% ophthalmic suspension
Dose Level B / Brinzolamide 1% ophthalmic suspension
Dose Level C / Brinzolamide 1% ophthalmic suspension
Brinzolamide 1% ophthalmic suspension AZOPT®
Travoprost 0.004% ophthalmic solution TRAVATAN Z®
Travoprost solution vehicle
Brinzolamide suspension vehicle
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 Glaucoma, Ocular, Hypertension, OAG, POAG, OHT

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
  • IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be >36 mmHg at any time point;
  • Able to understand and sign an informed consent form;
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study;
  • Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit;
  • Chronic, recurrent or severe inflammatory eye disease;
  • Ocular trauma within the past 6 months prior to the Screening Visit;
  • Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit;
  • Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;
  • Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
  • Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor;
  • Intraocular surgery within the past 6 months prior to the Screening Visit;
  • Ocular laser surgery within the past 3 months prior to the Screening Visit;
  • Any abnormality preventing reliable applanation tonometry;
  • Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
  • History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator;
  • Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator;
  • Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (> 1 g daily) salicylate therapy;
  • Use of any additional topical or systemic ocular hypotensive medication during the study;
  • Concurrent use of glucocorticoids administered by any route;
  • Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents);
  • Therapy with another investigational agent within 30 days prior to the Screening Visit;
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    TravA/Brinz

    TravB/Brinz

    TravC/Brinz

    AZOPT

    TRAV Z

    TRAV Z + AZOPT

    Arm Description

    Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks

    Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks

    Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks

    Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks

    Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks

    Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks

    Outcomes

    Primary Outcome Measures

    Mean IOP at Week 6
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2014
    Last Updated
    November 24, 2015
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02140060
    Brief Title
    6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
    Official Title
    A 6-Week Proof-of-Concept Study Evaluating the Safety and IOP-Lowering Efficacy of Travoprost/Brinzolamide Fixed Combination Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    November 2014 (Actual)
    Study Completion Date
    November 2014 (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 evaluate Travoprost/Brinzolamide fixed combination (Trav/Brinz) administered twice daily as compared to each of its marketed components (TRAVATAN Z® solution and AZOPT® suspension) and to the unfixed combination of TRAVATAN Z® plus AZOPT® in lowering intraocular pressure (IOP).
    Detailed Description
    This study was divided into two phases conducted in sequence. Phase I was the Screening/Eligibility Phase, which included a Screening Visit, followed by two Eligibility Visits. Phase II was the randomized, double-masked, 6-week Treatment Phase which included on-therapy visits at Week 2 and Week 6. Travoprost was administered in 1 of 3 concentration levels (A-C), where A=lowest and C=highest.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    Glaucoma, Ocular, Hypertension, OAG, POAG, OHT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    327 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TravA/Brinz
    Arm Type
    Experimental
    Arm Description
    Dose Level A / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
    Arm Title
    TravB/Brinz
    Arm Type
    Experimental
    Arm Description
    Dose Level B / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
    Arm Title
    TravC/Brinz
    Arm Type
    Experimental
    Arm Description
    Dose Level C / Brinzolamide 1% ophthalmic suspension (fixed combination), 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
    Arm Title
    AZOPT
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
    Arm Title
    TRAV Z
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
    Arm Title
    TRAV Z + AZOPT
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide 1% ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Dose Level A / Brinzolamide 1% ophthalmic suspension
    Intervention Description
    Fixed combination
    Intervention Type
    Drug
    Intervention Name(s)
    Dose Level B / Brinzolamide 1% ophthalmic suspension
    Intervention Description
    Fixed combination
    Intervention Type
    Drug
    Intervention Name(s)
    Dose Level C / Brinzolamide 1% ophthalmic suspension
    Intervention Description
    Fixed combination
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1% ophthalmic suspension AZOPT®
    Other Intervention Name(s)
    AZOPT®
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost 0.004% ophthalmic solution TRAVATAN Z®
    Other Intervention Name(s)
    TRAVATAN Z®
    Intervention Type
    Drug
    Intervention Name(s)
    Travoprost solution vehicle
    Intervention Description
    Inactive ingredients used for masking purposes
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide suspension vehicle
    Intervention Description
    Inactive ingredients used for masking purposes
    Primary Outcome Measure Information:
    Title
    Mean IOP at Week 6
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) was used for the analysis.
    Time Frame
    Week 6, 8 AM, 10 AM, 12 PM, 4 PM, and 8 PM

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with open-angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; IOP within the protocol-specified range at both the Eligibility 1 and 2 Visits. Mean IOP must not be >36 mmHg at any time point; Able to understand and sign an informed consent form; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Woman of childbearing potential who is currently pregnant, intends to become pregnant during the study period, breastfeeding, or not using adequate birth control methods to prevent pregnancy throughout the study; Unable to discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to the E1 Visit; Chronic, recurrent or severe inflammatory eye disease; Ocular trauma within the past 6 months prior to the Screening Visit; Ocular infection or ocular inflammation within the past 3 months prior to the Screening Visit; Clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment; Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal); Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of a topical prostaglandin analogue or topical carbonic anhydrase inhibitor; Intraocular surgery within the past 6 months prior to the Screening Visit; Ocular laser surgery within the past 3 months prior to the Screening Visit; Any abnormality preventing reliable applanation tonometry; Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study; History of hepatic or renal disease that would preclude the safe administration of a carbonic anhydrase inhibitor (CAI) in the opinion of the Investigator; Hypersensitivity to prostaglandin analogues, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications in the opinion of the Investigator; Recent (within 4 weeks of the Eligibility 1 Visit) use of high dose (> 1 g daily) salicylate therapy; Use of any additional topical or systemic ocular hypotensive medication during the study; Concurrent use of glucocorticoids administered by any route; Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding the IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP (ie, β adrenergic blocking agents); Therapy with another investigational agent within 30 days prior to the Screening Visit; Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sr. Clinical Manager, GCRA, Pharma
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    6-Week Proof-of-Concept Study of Travoprost/Brinzolamide Ophthalmic Suspension in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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