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

Completed · Phase 2

Conditions studied: Ocular Hypertension, Open Angle Glaucoma

In brief

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

Key facts

Study ID

NCT01731002

Run by

Aerie Pharmaceuticals

People needed

224

Starts

2012-11-01

Expected to finish

2013-05-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or greater.
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
• 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.
• 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
• Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
• IOP > 36 mm Hg.
• Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
• Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s, e.g., laser trabeculoplasty).
• Refractive surgery in study eye(s) (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser eye surgery (LASIK), etc.).
• Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months prior to screening.
• Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at screening (Visit 0), or a history of herpes simplex keratitis
• 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).
• 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).
• Central corneal thickness greater than 600 µm.
• Any abnormality preventing reliable applanation tonometry of either eye.
• Systemic:
• Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
• Known hypersensitivity or contraindication to latanoprost.
• Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
• Participation in any investigational study within 30 days prior to screening.
• Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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