Back to resultsEvaluation 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
About this trial
This is an interventional treatment trial for Glaucoma, Primary Open Angle
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
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
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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