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Clinical Trials/NCT02858284
NCT02858284TerminatedNot Applicable

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

EyeSonix0 sites25 target enrollmentStarted: July 1, 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
25
Primary Endpoint
Change in mean diurnal IOP
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Change in mean diurnal IOP

Time Frame: Week 4 (Visit 5) and Week 8 (Visit 7)

Change in mean IOP

Time Frame: through subject study completion; average 2 months

Change in IOP from baseline

Time Frame: through subject study completion; average 2 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
EyeSonix
Sponsor Class
Industry
Responsible Party
Sponsor

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