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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02858284
Recruitment Status : Completed
First Posted : August 8, 2016
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
EyeSonix

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 8, 2016
Last Update Posted Date February 21, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2016)
  • Change in mean IOP [ Time Frame: through subject study completion; average 2 months ]
  • Change in mean diurnal IOP [ Time Frame: Week 4 (Visit 5) and Week 8 (Visit 7) ]
  • Change in IOP from baseline [ Time Frame: through subject study completion; average 2 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Primary Open Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Device: TUG
    Therapeutic Ultrasound for Glaucoma
  • Device: Sham
Study Arms  ICMJE
  • Experimental: TUG Device
    1 time external application - device powered on
    Intervention: Device: TUG
  • Sham Comparator: Sham
    1 time external application - device powered off
    Intervention: Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2016)
25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 22, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02858284
Other Study ID Numbers  ICMJE TUG-US-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EyeSonix
Study Sponsor  ICMJE EyeSonix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EyeSonix
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP