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

NCT03233308 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AR-13324-CS206
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension

Keywords

Aqueous Humor Dynamics; Trabecular Outflow; Netarsudil

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility

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

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

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

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

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (2)

Netarsudil Ophthalmic Solution 0.02%

EXPERIMENTAL

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

Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator

Placebo Comparator

PLACEBO COMPARATOR

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

Drug: Netarsudil Ophthalmic Solution 0.02%; Other: Placebo Comparator

Interventions

Netarsudil Ophthalmic Solution 0.02% DRUG

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

Netarsudil Ophthalmic Solution 0.02%; Placebo Comparator

Placebo Comparator OTHER

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

Netarsudil Ophthalmic Solution 0.02%; Placebo Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Results Point of Contact

• Title: Theresa GH Heah, MD, MBA
• Organization: Aerie Pharmaceuticals, Inc

theah@aeriepharma.com

908-947-3844

Study Officials

• Nancy Ramirez-Davis

  Aerie Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Paired comparison study

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 28, 2017
• Study Start: October 20, 2017
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: August 6, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)