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

Sponsor

EyeSonix (Industry)

Overall Status

Terminated

CT.gov ID

NCT02858284

Collaborator

(none)

Enrollment

Arms

25.7

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle Ocular Hypertension	Device: TUG Device: Sham	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Aug 22, 2018

Actual Study Completion Date :

Aug 22, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in mean IOP [through subject study completion; average 2 months]
Change in mean diurnal IOP [Week 4 (Visit 5) and Week 8 (Visit 7)]
Change in IOP from baseline [through subject study completion; average 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

EyeSonix

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EyeSonix

ClinicalTrials.gov Identifier:

NCT02858284

Other Study ID Numbers:

TUG-US-001

First Posted:

Aug 8, 2016

Last Update Posted:

Apr 6, 2022

Last Verified:

Feb 1, 2019

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022