Glaucoma, Primary Open Angle, Ocular Hypertension
Conditions
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.
Interventions
DEVICETUG
Therapeutic Ultrasound for Glaucoma
DEVICESham
Sponsors
EyeSonix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed