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Sponsor request
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TUG Device | Experimental | 1 time external application - device powered on |
|
| Sham | Sham Comparator | 1 time external application - device powered off |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TUG | Device | Therapeutic Ultrasound for Glaucoma |
| |
| Sham |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Device |
|
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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