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

EyeSonix

Status

Terminated

Conditions

Glaucoma, Primary Open Angle

Ocular Hypertension

Treatments

Device: TUG

Device: Sham

Study type

Interventional

Funder types

Industry

Identifiers

NCT02858284

TUG-US-001

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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