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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

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Ocular Hypertension Device: TUG Device: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2016
Actual Primary Completion Date : August 22, 2018
Actual Study Completion Date : August 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: TUG Device
1 time external application - device powered on
Device: TUG
Therapeutic Ultrasound for Glaucoma

Sham Comparator: Sham
1 time external application - device powered off
Device: Sham



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858284


Locations
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United States, Massachusetts
North Shore Eye Care
Salem, Massachusetts, United States, 01970
United States, North Carolina
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
EyeSonix
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Responsible Party: EyeSonix
ClinicalTrials.gov Identifier: NCT02858284    
Other Study ID Numbers: TUG-US-001
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases