Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

A Phase 2, Double-masked, Randomized, Multi-center, Active-controlled, Dose-response Parallel-group Study Comparing the Safety and Ocular Hypotensive Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure

Double-masked, randomized, multi-center, dose-response, active-controlled parallel-comparison of AR-13324 to latanoprost

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: AR-13324 Ophthalmic Solution 0.01%; Drug: AR-13324 Ophthalmic Solution 0.02%; Drug: Latanoprost ophthalmic solution 0.005%

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Kenneth Sall, M.D.
    • Inglewood, California, United States, 90301
      • United Medical Research Institute
    • Newport Beach, California, United States, 92657
      • Aesthetic Eye Care Institute
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
    • Poway, California, United States, 92064
      • Centre For Health Care
  • Georgia
    • Morrow, Georgia, United States, 30260
      • Clayton Eye Center
    • Roswell, Georgia, United States, 30076
      • Coastal Research Associates, LLC
  • Kansas
    • Shawnee Mission, Kansas, United States, 66204
      • Bradley Kwapiszeski, MD
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Alan L Robin, M.D.
    • Havre De Grace, Maryland, United States, 21078
      • Seidenberg Protzko Eye Associates
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Great Lakes Eye Care
  • New York
    • Lynbrook, New York, United States, 11563
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat
    • High Point, North Carolina, United States, 27262
      • Michael E. Tepedino, M.D.
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • The Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Hospital
  • Texas
    • Austin, Texas, United States, 78731
      • Texan Eye
    • El Paso, Texas, United States, 79902
      • Cataract & Glaucoma Center
    • San Antonio, Texas, United States, 78731
      • Medical Center Ophth. Associates
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Eye Consultants

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) Intraocular Pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (08:00 hr), 2-7 days a part, and ≥ 22 mm Hg at 10:00 and 16:00 hrs at the second qualification visit. If only one eye meets the IOP criteria it must be the same eye that met the criteria at all the qualification timepoints.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
2. IOP > 36 mm Hg.
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
4. Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s, e.g., laser trabeculoplasty).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).
6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.
7. Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis
8. Ocular medication of any kind within 30 days of Visit 0, 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 0) or c) lubricating drops for dry eye (which may be used throughout the study).
9. Clinically significant ocular disease (e.g. 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 (i.e., cup-disc ratio > 0.8).
10. Central corneal thickness greater than 600 µm.

11. Any abnormality preventing reliable applanation tonometry of either eye.

    Systemic:

12. Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
13. Known hypersensitivity or contraindication to latanoprost.
14. Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
15. Participation in any investigational study within 30 days prior to screening.
16. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
17. Due to the current status of the preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the screening examination and must not intend to become pregnant during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AR-13324 Ophthalmic Solution 0.01%; 1 drop to study eye once daily	Drug: AR-13324 Ophthalmic Solution 0.01%; Administered to study eye, once daily (QD) in the evening (PM) for 28 days
Experimental: AR-13324 Ophthalmic Solution 0.02%; 1 drop to study eye once daily	Drug: AR-13324 Ophthalmic Solution 0.02%; Administered to study eye, QD in the PM for 28 days; Other Names: Netarsudil
Active Comparator: Latanoprost Ophthalmic Solution 0.005%; 1 drop to study eye once daily	Drug: Latanoprost ophthalmic solution 0.005%; Administered to study eye, QD in the PM for 28 days; Other Names: Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP)	The primary efficacy endpoint was the mean IOP across subjects within treatment group on each day at each post-treatment timepoint. IOP was measured at 0800, 1000, and 1600 hours on days 0, 14, and 28. IOP was also measured at 0800 hours on Day 7 and follow-up days 29 and 30.	Study treatment was administered for 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Extent of Exposure	Exposure to study medication in days for all treatment groups.	28 Days

Collaborators and Investigators

• Sponsor: Aerie Pharmaceuticals
• Investigators: Study Director: Theresa Heah, MD, Aerie Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: AR-13324-CS202