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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 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.

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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.

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

FieldValue
Enrollment Target 64 participants
Start Date 2020-10-28
Est. Completion 2021-08-19
Phase NA

Sponsor

Equinox

1 total trials

What the Registry Record Tells You About NCT04632329

The ClinicalTrials.gov registry entry for NCT04632329 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 162-participant average among 22 other Glaucoma Open-Angle trials with a reported enrollment target (60% lower). The listed sponsor is Equinox, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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.

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