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TerminatedNCT02858284Updated Apr 6, 2022

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

An interventional study of TUG and Sham in Glaucoma, Primary Open Angle and Ocular Hypertension, sponsored by EyeSonix. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.

Sponsored by EyeSonix · Not applicable, Interventional, and Treatment

Why this study was terminated
Sponsor request
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma, Primary Open Angle
  • Ocular Hypertension
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 25 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

This is the only study on the registry with EyeSonix as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    TUG Device

    1 time external application - device powered on

    Device: TUG

  • Sham comparator
    Sham

    1 time external application - device powered off

    Device: Sham

Interventions

  • DeviceTUG

    Therapeutic Ultrasound for Glaucoma

  • DeviceSham
06

What researchers measure

Primary outcomes

  1. Change in mean IOP

    Time frame: through subject study completion; average 2 months

  2. Change in mean diurnal IOP

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

  3. Change in IOP from baseline

    Time frame: through subject study completion; average 2 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02858284
Lead sponsor
EyeSonix
Responsible party
Sponsor
First posted
Aug 8, 2016
Start date
Jul 1, 2016
Primary completion
Aug 22, 2018
Completion
Aug 22, 2018
Last update
Apr 6, 2022
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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