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

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.

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