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Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma

Primary Purpose

Glaucoma, Open-Angle

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Negative Pressure Treatment via the Mercury Multi-Pressure Dial

About this trial

This is an interventional device feasibility trial for Glaucoma, Open-Angle

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Illinois College of Optometry
Vance Thompson Vision
R and R Eye Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Negative Pressure

Control Eye

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04632329

First Posted

October 31, 2020

Last Updated

November 7, 2022

Sponsor

Equinox

1. Study Identification

Unique Protocol Identification Number

NCT04632329

Brief Title

Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

October 28, 2020 (Actual)

Primary Completion Date

August 19, 2021 (Actual)

Study Completion Date

August 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Equinox

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Negative Pressure

Arm Type

Experimental

Arm Title

Control Eye

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Negative Pressure Treatment via the Mercury Multi-Pressure Dial

Intervention Description

Negative Pressure Treatment via the Mercury Multi-Pressure Dial

Primary Outcome Measure Information:

Title

IOP* reduction of ≥ 20% with 50% Negative Pressure for the treatment group vs. the control group

Description

Time Frame

Day 1

Title

Mean IOP*reduction with 50% Negative Pressure for the treatment group vs. the control group

Description

Time Frame

Day 1

Secondary Outcome Measure Information:

Title

IOP* reduction of ≥ 25% with 75% Negative Pressure for the treatment group vs. the control group

Description

*Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure

Time Frame

Day 1

Title

Mean IOP*reduction with 75% Negative Pressure for the treatment group vs. the control group

Description

*Difference in IOP as measured via pneumatonometry with Excursion goggles worn immediately before vs. during application of negative pressure

Time Frame

Day 1

Other Pre-specified Outcome Measures:

Title

Adverse Biomicroscopic Slit Lamp Findings

Description

Slit lamp findings before and after negative pressure applications

Time Frame

Day 1

Title

Rate of ocular/periocular adverse events (% by adverse event)

Description

Safety Outcomes

Time Frame

Day 1

Title

Corrected Distance Visual Acuity

Description

Safety Outcomes

Time Frame

Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nate Radliffe, MD

Organizational Affiliation

New York Eye Surgery Center

Official's Role

Study Director

Facility Information:

Facility Name

Illinois College of Optometry

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Vance Thompson Vision

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57108

Country

United States

Facility Name

R and R Eye Research, LLC

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma

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