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

Results pending

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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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2018-08-22

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma, Primary Open Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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TUG Device

1 time external application - device powered on

Group Type EXPERIMENTAL

TUG

Intervention Type DEVICE

Therapeutic Ultrasound for Glaucoma

Sham

1 time external application - device powered off

Group Type SHAM_COMPARATOR

Sham

Intervention Type DEVICE

Interventions

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TUG

Therapeutic Ultrasound for Glaucoma

Intervention Type DEVICE

Sham

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EyeSonix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TUG-US-001

Identifier Type: -

Identifier Source: org_study_id

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