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NCT04632329 · ClinicalTrials.gov registry record · NA
Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma
A NA study of Glaucoma Open-Angle, sponsored by Equinox.
- Completed
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 3
- Study locations
NCT04632329: Completed NA study of Glaucoma Open-Angle, sponsored by Equinox.
NCT04632329 is a NA study of Glaucoma Open-Angle that has completed, run by Equinox. The registered enrollment target is 64 participants, below the 162-participant average among 22 other Glaucoma Open-Angle trials with a reported enrollment target (60% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04632329, a NA study of Glaucoma Open-Angle, has completed, sponsored by Equinox.
- COMPLETED
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 3
- Study locations
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Negative Pressure Treatment via the Mercury Multi-Pressure Dial
Study Locations (3)
Illinois
- Illinois College of Optometry - Chicago
South Dakota
- Vance Thompson Vision - Sioux Falls
Texas
- R and R Eye Research, LLC - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-10-28 |
| Est. Completion | 2021-08-19 |
| Phase | NA |
What the finished NCT04632329 record still lists
NCT04632329 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 162-participant average among 22 other Glaucoma Open-Angle trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Glaucoma Open-Angle appearing as the primary indexed condition, and to 1 intervention - of which Negative Pressure Treatment via the Mercury Multi-Pressure Dial is the first listed.
NCT04632329 reports a single indexed study location in Illinois, South Dakota, Texas.
Frequently Asked Questions
What is clinical trial NCT04632329 about?
NCT04632329 is a clinical study titled "Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma". 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 glaucom...
What is the current status of trial NCT04632329?
This trial is currently completed. It is a NA study. The enrollment target is 64 participants. The study started on 2020-10-28. Estimated completion is 2021-08-19.
What conditions does trial NCT04632329 study?
This clinical trial studies the following conditions: Glaucoma Open-Angle.
What interventions are being tested in trial NCT04632329?
The interventions under investigation include: Negative Pressure Treatment via the Mercury Multi-Pressure Dial (DEVICE).
Who is sponsoring clinical trial NCT04632329?
This trial is sponsored by Equinox, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04632329 being conducted?
This trial has 3 study locations across Illinois, South Dakota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04632329's enrollment target sits among peer trials
64 16th of 22 higher than 7 of 22 other Glaucoma Open-Angle trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma Open-Angle trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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