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Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Primary Open Angle, Ocular Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TUG
Sham
Sponsored by
EyeSonix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Primary Open Angle

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes
  • Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study
  • Be willing to provide written informed consent
  • Be willing and able to follow instructions
  • A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential)

Exclusion Criteria:

  • Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye
  • Prior or anticipated concurrent use of an investigational drug or device
  • Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
  • Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    TUG Device

    Sham

    Arm Description

    1 time external application - device powered on

    1 time external application - device powered off

    Outcomes

    Primary Outcome Measures

    Change in mean IOP
    Change in mean diurnal IOP
    Change in IOP from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    August 1, 2016
    Last Updated
    March 28, 2022
    Sponsor
    EyeSonix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02858284
    Brief Title
    Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension
    Official Title
    A Multi-Center, Randomized, Double-Masked, 8-week Pilot Study Evaluating the Safety and Efficacy of the TUG (Therapeutic Ultrasound for Glaucoma) Compared to Sham in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Sponsor request
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    August 22, 2018 (Actual)
    Study Completion Date
    August 22, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EyeSonix

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate whether the TUG device is safe and effective in patients with primary 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
    Glaucoma, Primary Open Angle, Ocular Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TUG Device
    Arm Type
    Experimental
    Arm Description
    1 time external application - device powered on
    Arm Title
    Sham
    Arm Type
    Sham Comparator
    Arm Description
    1 time external application - device powered off
    Intervention Type
    Device
    Intervention Name(s)
    TUG
    Intervention Description
    Therapeutic Ultrasound for Glaucoma
    Intervention Type
    Device
    Intervention Name(s)
    Sham
    Primary Outcome Measure Information:
    Title
    Change in mean IOP
    Time Frame
    through subject study completion; average 2 months
    Title
    Change in mean diurnal IOP
    Time Frame
    Week 4 (Visit 5) and Week 8 (Visit 7)
    Title
    Change in IOP from baseline
    Time Frame
    through subject study completion; average 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Diagnosis of primary open angle glaucoma or ocular hypertension in both eyes Be willing to discontinue disallowed products and/or medications during the period indicated prior to participation or throughout the study Be willing to provide written informed consent Be willing and able to follow instructions A negative urine pregnancy test and agree to an acceptable form of contraception for the duration of the study (if female of childbearing potential) Exclusion Criteria: Any form of glaucoma other than primary open angle glaucoma or ocular hypertension in either eye Prior or anticipated concurrent use of an investigational drug or device Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test Have a condition (ocular or systemic) or a situation which, in the Investigator's opinion, may put the subject at increased risk, may confound study data, or may interfere significantly with the subject's study participation

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension

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