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Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Primary Purpose

Primary Open Angle Glaucoma or Ocular Hypertension

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Netarsudil Ophthalmic Solution 0.02%

Placebo Comparator

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma or Ocular Hypertension focused on measuring Aqueous Humor Dynamics, Trabecular Outflow, Netarsudil

Eligibility Criteria

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

Inclusion Criteria:

Must be 18 years of age or older
Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

Clinically significant ocular disease
Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
Intraocular pressure ≥30 mmHg in either eye
A difference in IOP between eyes >4mmHg at qualification visit
Use of more than two ocular hypotensive medications within 30 days of screening
Known hypersensitivity to any component of the formulation
Previous glaucoma surgery or refractive surgery
Keratorefractive surgery in either eye
Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
Recent or current ocular infection or inflammation in either eye
Use of ocular medication in either eye of any kind within 30 days of screening
Mean central corneal thickness greater than 620 μm in either eye
Any abnormality preventing reliable applanation tonometry of either eye
Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
Systemic:
Clinically significant abnormalities within 6 weeks prior to screening
Clinically significant systemic disease
Participation in any investigational study within 60 days prior to screening
Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Sites / Locations

Mayo Clinic
Duke Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Netarsudil Ophthalmic Solution 0.02%

Placebo Comparator

Arm Description

Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye

Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye

Outcomes

Primary Outcome Measures

Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility

Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.

Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

Secondary Outcome Measures

Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)

Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

Full Information

NCT ID

NCT03233308

First Posted

July 12, 2017

Last Updated

July 29, 2019

Sponsor

Aerie Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03233308

Brief Title

Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Official Title

A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

October 20, 2017 (Actual)

Primary Completion Date

April 19, 2018 (Actual)

Study Completion Date

April 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aerie Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo

Detailed Description

Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.

6. Conditions and Keywords

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

Primary Open Angle Glaucoma or Ocular Hypertension

Keywords

Aqueous Humor Dynamics, Trabecular Outflow, Netarsudil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Paired comparison study

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Netarsudil Ophthalmic Solution 0.02%

Arm Type

Experimental

Arm Description

Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye

Intervention Type

Drug

Intervention Name(s)

Netarsudil Ophthalmic Solution 0.02%

Intervention Description

1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye

Intervention Type

Other

Intervention Name(s)

Placebo Comparator

Intervention Description

1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye

Primary Outcome Measure Information:

Title

Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility

Description

Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

Time Frame

Study treatment was administered for 7 days, and outcome measures collected on Day 8

Title

Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.

Description

Mean diurnal change from baseline in trabecular (tonographic) outflow facility.

Time Frame

Study treatment was administered for 7 days, and outcome measures collected on Day 8

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

Description

Time Frame

Study treatment was administered for 7 days, and outcome measures collected on Day 8

Title

Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)

Description

Time Frame

Study treatment was administered for 7 days, and outcome measures collected on Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be 18 years of age or older Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better Able to give informed consent and follow study instructions Exclusion Criteria: Ophthalmic: Clinically significant ocular disease Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles Intraocular pressure ≥30 mmHg in either eye A difference in IOP between eyes >4mmHg at qualification visit Use of more than two ocular hypotensive medications within 30 days of screening Known hypersensitivity to any component of the formulation Previous glaucoma surgery or refractive surgery Keratorefractive surgery in either eye Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening Recent or current ocular infection or inflammation in either eye Use of ocular medication in either eye of any kind within 30 days of screening Mean central corneal thickness greater than 620 μm in either eye Any abnormality preventing reliable applanation tonometry of either eye Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only) Systemic: Clinically significant abnormalities within 6 weeks prior to screening Clinically significant systemic disease Participation in any investigational study within 60 days prior to screening Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nancy Ramirez-Davis

Organizational Affiliation

Aerie Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Duke Eye Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

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