Glaucoma, Primary Open AngleNCT02858284
Evaluation of Safety and Efficacy of TUG (Therapeutic Ultrasound for Glaucoma) in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension
A study testing TUG in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by EyeSonix.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle, Ocular Hypertension
- What is being tested?
- TUG
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 22 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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.
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Being tested
- TUG, Sham
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TUGDevice
Therapeutic Ultrasound for Glaucoma
ShamDevice
| Study group | Role | What they receive |
|---|---|---|
| TUG Device | Experimental | 1 time external application - device powered on Receives: Device: TUG |
| Sham | Sham comparator | 1 time external application - device powered off Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean IOP
Measured: through subject study completion; average 2 months
Change in mean diurnal IOP
Measured: Week 4 (Visit 5) and Week 8 (Visit 7)
Change in IOP from baseline
Measured: through subject study completion; average 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start1 Jul 2016
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Why it stopped: Sponsor request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeSonix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858284
- Sponsor's protocol ID
- TUG-US-001
- Status last verified
- Feb 2019
- First submitted
- 1 Aug 2016
- Last updated
- 6 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02858284
- Acronym / sponsor ID
- TUG-US-001
- Conditions
- Glaucoma, Primary Open Angle, Ocular Hypertension
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor request
- Enrolment
- 25 participants (actual)
- Lead sponsor
- EyeSonixIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TUG Device | Experimental | Device: TUG1 time external application - device powered on |
| Sham | Sham comparator | Device: Sham1 time external application - device powered off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TUGTherapeutic Ultrasound for Glaucoma | Device | TUG Device |
| Sham | Device | Sham |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing TUG in people with Glaucoma, Primary Open Angle and Ocular Hypertension, run by EyeSonix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor request). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean IOP (time frame: through subject study completion; average 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.