Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension
NCT ID: NCT02858284
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2016-07-01
2018-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TUG Device
1 time external application - device powered on
TUG
Therapeutic Ultrasound for Glaucoma
Sham
1 time external application - device powered off
Sham
Interventions
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TUG
Therapeutic Ultrasound for Glaucoma
Sham
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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EyeSonix
INDUSTRY
Responsible Party
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Other Identifiers
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TUG-US-001
Identifier Type: -
Identifier Source: org_study_id
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