Glaucoma, Open-AngleNCT04632329
Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma
A study testing Negative Pressure Treatment via the Mercury Multi-Pressure Dial in people with Glaucoma, Open-Angle, run by Equinox at 3 sites in United States.
Trial summary
This is a prospective, non-significant risk, controlled, randomized, multi-center, masked, feasibility study to evaluate the safety and IOP-lowering effectiveness of negative pressure application (via the Mercury MPD) for lowering and titrating intraocular pressure (IOP) in severe open-angle glaucoma (OAG) patients. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Negative Pressure Treatment via the Mercury Multi-Pressure Dial
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Oct 2020to 19 Aug 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 22 years of age at the time of signing the informed consent
- Subjects willing to sign the informed consent and capable of committing to the study assessments
- Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can obtain IOP measurements with Excursion goggles in place
- Subjects with a diagnosis of severe open-angle glaucoma (OAG definition is inclusive of primary open angle glaucoma, normal tension glaucoma, pseudoexfoliative glaucoma, and pigmentary glaucoma) in at least one eye, defined by glaucomatous optic disc or RNFL abnormalities AND visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one hemifield as tested with standard automated perimetry (the diagnosis of the contralateral eye may include suspected OAG< as well as mild/moderate/severe OAG)
- Subjects with treatment regimens including current ocular hypotensive medications, prior non-incisional surgical procedures (e.g. MIGS and SLT), or any combination of the two
- Subjects who are literate, able to speak English or Spanish, and able to understand and follow study instructions
Who cannot join
- Subjects with a history of allergy to primary study device material (i.e., silicone and latex)
- Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
- Subjects with a history of retinal tear/detachment, wet macular degeneration, diabetic macular edema, or proliferative diabetic retinopathy
- Subjects with active conjunctival chemosis or anterior uveitis
- Subjects with a Van Herick grade of 2 or less.
- Subjects with a history of prior incisional filtering (i.e. trabeculectomy) or tube/shunt glaucoma surgery in either eye
- Subjects with best corrected visual acuity of 20/200 or worse in either eye due to glaucoma
- Subjects who do not wish to or cannot comply with study procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Illinois College of Optometry
Chicago, Illinois, 60616
R and R Eye Research, LLC
San Antonio, Texas, 78229
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
Official title: Negative Pressure Applied by the Equinox Mercury™ Multi-Pressure Dial to Lower and Modulate Intraocular Pressure in Subjects With Severe Open Angle Glaucoma (The Ranger Study)
This is a prospective, non-significant risk, controlled, randomized, multi-center, masked, feasibility study to evaluate the safety and IOP-lowering effectiveness of negative pressure application (via the Mercury MPD) for lowering and titrating intraocular pressure (IOP) in severe open-angle glaucoma (OAG) patients. The study will be conducted at approximately three investigational sites in the United States. Between 60 and 100 subjects will be randomized to treatment. Treatment eyes will be administered two levels of negative pressure, calculated based on 50% and 75% of baseline IOP (as measured by pneumatonometry). One eye of each eligible subject will be randomized to receive negative pressure application with the MPD device; the contralateral eye will be used as a control and will be examined but will not undergo application of negative pressure. Subjects will be treated at each of the negative pressure levels for one hour. All study procedures will be conducted at one visit, and the subject will exit the study at the conclusion of the visit.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Negative Pressure Treatment via the Mercury Multi-Pressure Dial
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Treatment via the Mercury Multi-Pressure DialDevice
Negative Pressure Treatment via the Mercury Multi-Pressure Dial
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure | Experimental | Not described Receives: Device: Negative Pressure Treatment via the Mercury Multi-Pressure Dial |
| Control Eye | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP* reduction of ≥ 20% with 50% Negative Pressure for the treatment group vs. the control group
Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure.
Measured: Day 1
Mean IOP*reduction with 50% Negative Pressure for the treatment group vs. the control group
Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. *Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure
Measured: Day 1
Secondary outcomes (2)
IOP* reduction of ≥ 25% with 75% Negative Pressure for the treatment group vs. the control group
*Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure
Measured: Day 1
Mean IOP*reduction with 75% Negative Pressure for the treatment group vs. the control group
*Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start28 Oct 2020
- Primary completion19 Aug 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Equinox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nate Radliffe, MD, Study director, New York Eye Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632329
- Sponsor's protocol ID
- CP-022
- Status last verified
- Nov 2022
- First submitted
- 31 Oct 2020
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Applied by the Equinox Mercury™ Multi-Pressure Dial to Lower and Modulate Intraocular Pressure in Subjects With Severe Open Angle Glaucoma (The Ranger Study)
- ClinicalTrials.gov ID
- NCT04632329
- Acronym / sponsor ID
- CP-022
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- EquinoxIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- 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.
This is a prospective, non-significant risk, controlled, randomized, multi-center, masked, feasibility study to evaluate the safety and IOP-lowering effectiveness of negative pressure application (via the Mercury MPD) for lowering and titrating intraocular pressure (IOP) in severe open-angle glaucoma (OAG) patients. The study will be conducted at approximately three investigational sites in the United States. Between 60 and 100 subjects will be randomized to treatment. Treatment eyes will be administered two levels of negative pressure, calculated based on 50% and 75% of baseline IOP (as measured by pneumatonometry). One eye of each eligible subject will be randomized to receive negative pressure application with the MPD device; the contralateral eye will be used as a control and will be examined but will not undergo application of negative pressure. Subjects will be treated at each of the negative pressure levels for one hour. All study procedures will be conducted at one visit, and the subject will exit the study at the conclusion of the visit.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure | Experimental | Device: Negative Pressure Treatment via the Mercury Multi-Pressure Dial |
| Control Eye | No intervention | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects ≥ 22 years of age at the time of signing the informed consent
- Subjects willing to sign the informed consent and capable of committing to the study assessments
- Subjects with orbital anatomy that permits a proper seal in both eyes when goggles are placed over eyes and can obtain IOP measurements with Excursion goggles in place
- Subjects with a diagnosis of severe open-angle glaucoma (OAG definition is inclusive of primary open angle glaucoma, normal tension glaucoma, pseudoexfoliative glaucoma, and pigmentary glaucoma) in at least one eye, defined by glaucomatous optic disc or RNFL abnormalities AND visual field abnormalities in both hemifields and/or loss within 5 degrees of fixation in at least one hemifield as tested with standard automated perimetry (the diagnosis of the contralateral eye may include suspected OAG< as well as mild/moderate/severe OAG)
- Subjects with treatment regimens including current ocular hypotensive medications, prior non-incisional surgical procedures (e.g. MIGS and SLT), or any combination of the two
Key exclusion criteria (8 listed)
- Subjects with a history of allergy to primary study device material (i.e., silicone and latex)
- Subjects with a history of any ocular disorder or condition (e.g., corneal transplant) in either eye that would likely interfere with the interpretation of the study results or compromise subject safety
- Subjects with a history of retinal tear/detachment, wet macular degeneration, diabetic macular edema, or proliferative diabetic retinopathy
- Subjects with active conjunctival chemosis or anterior uveitis
- Subjects with a Van Herick grade of 2 or less.
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 |
|---|---|---|
| Negative Pressure Treatment via the Mercury Multi-Pressure DialNegative Pressure Treatment via the Mercury Multi-Pressure Dial | Device | Negative Pressure |
Primary outcome
IOP* reduction of ≥ 20% with 50% Negative Pressure for the treatment group vs. the control group
Time frame: Day 1
Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure.
Mean IOP*reduction with 50% Negative Pressure for the treatment group vs. the control group
Time frame: Day 1
Feasibility to lower intraocular pressure inside the eye in 1 treatment session (1-day). Not a measure of glaucoma progression health outcome. *Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure
2 secondary outcomes
IOP* reduction of ≥ 25% with 75% Negative Pressure for the treatment group vs. the control group
Time frame: Day 1
Mean IOP*reduction with 75% Negative Pressure for the treatment group vs. the control group
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 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.
Nate Radliffe, MD study director
New York Eye Surgery Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Treatment via the Mercury Multi-Pressure Dial in people with Glaucoma, Open-Angle, run by Equinox at 3 sites in United States.
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 8 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: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IOP* reduction of ≥ 20% with 50% Negative Pressure for the treatment group vs. the control group (time frame: Day 1). The study lists 2 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 10 Nov 2022.