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NCT02858284 Clinical Trial

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

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02858284
Other study ID # TUG-US-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date August 22, 2018

Study information
Verified date February 2019
Source EyeSonix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TUG
Therapeutic Ultrasound for Glaucoma
• Sham

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
EyeSonix

Outcome
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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