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

March 28, 2022 updated by: EyeSonix

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TUG Device
1 time external application - device powered on
Device: TUG
Therapeutic Ultrasound for Glaucoma
SHAM_COMPARATOR: Sham
1 time external application - device powered off
Device: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in mean IOP
Time Frame: through subject study completion; average 2 months
through subject study completion; average 2 months
Change in mean diurnal IOP
Time Frame: Week 4 (Visit 5) and Week 8 (Visit 7)
Week 4 (Visit 5) and Week 8 (Visit 7)
Change in IOP from baseline
Time Frame: through subject study completion; average 2 months
through subject study completion; average 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EyeSonix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

August 22, 2018

Study Completion (ACTUAL)

August 22, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (ESTIMATE)

August 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUG-US-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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