Clinical trial NCT01731002: Study Comparing the Safety and Efficacy of AR-13324 to Latanoprost in Patients With Elevated Intraocular Pressure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Keywords: Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Study treatment was administered for 28 days
Secondary outcomes:
measure: Extent of Exposure
timeFrame: 28 Days
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Kenneth Sall, M.D.
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: Aesthetic Eye Care Institute
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates
state: California
city: Poway
country: United States
facility: Centre For Health Care
state: California
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Roswell
country: United States
facility: Coastal Research Associates, LLC
state: Georgia
city: Shawnee Mission
country: United States
facility: Bradley Kwapiszeski, MD
state: Kansas
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Baltimore
country: United States
facility: Alan L Robin, M.D.
state: Maryland
city: Havre De Grace
country: United States
facility: Seidenberg Protzko Eye Associates
state: Maryland
city: Saint Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmological Group
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat
state: North Carolina
city: High Point
country: United States
facility: Michael E. Tepedino, M.D.
state: North Carolina
city: Tulsa
country: United States
facility: The Eye Institute
state: Oklahoma
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: El Paso
country: United States
facility: Cataract & Glaucoma Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophth. Associates
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: Theresa Heah, MD
role: STUDY_DIRECTOR
References: