Study of AR-13324 in Patients With Elevated Intraocular Pressure

NCT01528787 | Completed Phase 2 Results

• 1 other identifier: AR-13324-CS201
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 11

Brief Summary

In this double-masked, vehicle-controlled, dose-response study, subjects will be randomized to receive AR-13324 Ophthalmic Solution 0.01%, 0.02%, and 0.04% or its vehicle (one eye), once daily (QD)in the morning (AM) for 7 days. The first dose and last dose will be administered in the clinic. Ocular safety and ocular hypotensive efficacy will be evaluated in the clinic throughout the study.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Keywords

Intraocular pressure; visual field; Ocular hypertension or open angle glaucoma

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  The primary efficacy outcome was the mean IOP across subjects within treatment group at each post-treatment timepoint of Day 8. Instillation of study treatment commenced on Day 2 following measurement of IOP. IOP was measured at 0800, 1000, 1200 and 1600 hours on days 2 and 8. IOP was also measured at 0800 hours on Day 4.

  Study treatment was administered for 7 days; starting on Day 2 and ending on Day 8.

Study Arms (4)

AR-13324 Ophthalmic Solution 0.01%

EXPERIMENTAL

1 drop to study eye once daily

Drug: AR-13324 Ophthalmic Solution 0.01%

AR-13324 Ophthalmic Solution 0.02%

EXPERIMENTAL

1 drop to study eye once daily

Drug: AR-13324 Ophthalmic Solution 0.02%

AR-13324 Ophthalmic Solution 0.04%

EXPERIMENTAL

1 drop to study eye once daily

Drug: AR-13324 Ophthalmic Solution 0.04%

AR-13324 Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

1 drop to study eye once daily

Other: AR-13324 Ophthalmic Solution Vehicle

Interventions

AR-13324 Ophthalmic Solution 0.01% DRUG

Administered to study eye, once daily (QD) in the morning (AM) for 7 days

AR-13324 Ophthalmic Solution 0.01%

AR-13324 Ophthalmic Solution 0.02% DRUG

Administered to study eye, QD AM for 7 days

Also known as: Netarsudil

AR-13324 Ophthalmic Solution 0.02%

AR-13324 Ophthalmic Solution 0.04% DRUG

Administered to study eye, QD AM for 7 days

AR-13324 Ophthalmic Solution 0.04%

AR-13324 Ophthalmic Solution Vehicle OTHER

Administered to study eye, QD AM for 7 days

AR-13324 Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or greater. 18 years of age or greater.
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
• Unmedicated (post-washout, p.r.n.) IOP ≥ 24 mm Hg in one or both eyes at 08:00 hours, ≥ 21 mm Hg at 10:00, 12:00 and 16:00 hours on post-washout measurement (Visit 1).
• Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
• Able and willing to give signed informed consent and follow study instructions.

You may not qualify if:

• Ophthalmic: Either eye
• Intraocular pressure \> 36 mm Hg
• Known hypersensitivity to any component of the formulation or to topical anesthetics, (benzalkonium chloride, etc.)
• Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or history of herpes simplex keratitis.
• Contact lens wear within 30 minutes of instillation of study medication.
• Ocular medication of any kind within 30 days of Visit 2, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 2) or c) lubricating drops for dry eye (which may be used throughout the study),
• Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe (e.g., advanced glaucomatous optic nerve head or visual field loss).
• Any abnormality preventing reliable applanation tonometry in either eye. Study eye:
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of acute angle-closure glaucoma, or closed or narrow angle upon gonioscopy. Note: Previous laser peripheral iridotomy is NOT acceptable.
• Previous glaucoma intraocular surgery or laser procedures such as argon laser trabeculoplasty (ALT), selective laser trabeculoplasty (SLT) or micropulse laser trabeculoplasty ( MLT), as well as refractive procedures such as radio keratotomy (RK), laser eye surgery (LASIK), photorefractive keratectomy (PRK), or collagen cross linking.
• Central corneal thickness greater than 600 μm.
• General/Systemic:
• Clinically significant abnormalities in laboratory tests at screening, recognizing that subjects are not fasting at the time of drawing blood.
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.

Sponsors & Collaborators

• Aerie Pharmaceuticals: lead

Study Sites (11)

Aesthetic Eye Care Institute

Newport Beach, California, 92657, United States

Location

Robert Noecker, M.D., M.B.A.

Fairfield, Connecticut, 06824, United States

Location

Coastal Research Associates, LLC

Roswell, Georgia, 30076, United States

Location

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 66204, United States

Location

Comprehensive Eye Care

St Louis, Missouri, 63090, United States

Location

Rochester Ophthalmology Group

Rochester, New York, 14618, United States

Location

The Eye Institute

Tulsa, Oklahoma, 74104, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Univ Eye Surgeons, Maryville Ctr.

Maryville, Tennessee, 37803, United States

Location

Texan Eye

Austin, Texas, 78731, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

netarsudil

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Results Point of Contact

• Title: Nancy Ramirez-Davis, Director Clinical Project Management
• Organization: Aerie Pharmaceuticals, Inc.

nramirez@aeriepharma.com

908-947-3543

Study Officials

• Theresa Heah, MD

  Aerie Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: February 5, 2012
• First Posted: February 8, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 18, 2018
• Results First Posted: February 22, 2018

Record last verified: 2016-06

Locations

US (11)