Ocular Hypertension Clinical Trial
Official title:
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
Verified date | February 2019 |
Source | EyeSonix |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 25 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 22, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
EyeSonix |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in mean IOP | through subject study completion; average 2 months | ||
Primary | Change in mean diurnal IOP | Week 4 (Visit 5) and Week 8 (Visit 7) | ||
Primary | Change in IOP from baseline | through subject study completion; average 2 months |
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