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

Not Applicable

Terminated

• Conditions: Glaucoma, Primary Open Angle; Ocular Hypertension
• Interventions: Device: TUG; Device: Sham

• Registration Number: NCT02858284
• Lead Sponsor: EyeSonix

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-08-03
• Study First Posted: 2016-08-08
• Primary Completion: 2018-08-22
• Study Completion: 2018-08-22
• Status Verified: 2019-02
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TUG Device	TUG	1 time external application - device powered on
Sham	Sham	1 time external application - device powered off

Primary Outcome Measures

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