Clinical trial NCT01060579: Study of AR-12286 Versus Latanoprost in Patients With Elevated Intraocular Pressure
Official title: A Phase 2, Double-masked, Randomized, Active-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) and currently being treated with ocular hypotensive medication.
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 eligibility visits (07:00-09:00 hr), 2-7 days apart.
4. Corrected visual acuity in each eye +1.0 logMAR or better by ETDRS in each eye (equivalent to 20/200).
5. Has used a commercially available IOP-lowering medication in one or both eyes for at least 30 days over the 90 days prior to the screening visit.
6. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic (in either eye):

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure. Note: Previous laser peripheral iridotomy is acceptable.
2. Intraocular pressure \> 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).
5. Refractive surgery in study eye(s) (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Ocular trauma within the past six months, or ocular surgery or laser treatment within the past three months.
7. History or evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or of herpes simplex keratitis
8. Contact lens wear within 30 minutes of instillation of study medication.
9. Ocular medication of any kind within 30 days of Visit 1, 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 1) or c) lubricating drops for dry eye (which may be used throughout the study).
10. 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 (i.e., cup-disc ratio \> 0.8).
11. Central corneal thickness greater than 600 μ.
12. Any abnormality preventing reliable applanation tonometry of either eye.

Systemic:

1. Clinically significant abnormalities in laboratory tests at screening.
2. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
3. Participation in any investigational study within the past 30 days.
4. Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
5. Due to status of 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: The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint
timeFrame: 28 days of dosing
Secondary outcomes:
measure: Mean change from diurnally adjusted baseline IOP at each timepoint
timeFrame: 28 days of dosing
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: United Medical Research 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: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tamarac
country: United States
facility: Marvin Greenberg, MD
state: Florida
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: St Louis
country: United States
facility: Comprehensive Eye Care
state: Missouri
city: New York
country: United States
facility: Mount Sinai School Of Medicine
state: New York
city: Rochester
country: United States
facility: Rochester Ophthalmology Group
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat
state: North Carolina
city: Tulsa
country: United States
facility: The Eye Institute
state: Oklahoma
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Maryville
country: United States
facility: Univ Eye Surgeons, Maryville Ctr.
state: Tennessee
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophth. Associates
state: Texas
Study officials:
affiliation: Aerie Pharmaceuticals, Inc.
name: Thomas van Haarlem, MD
role: STUDY_DIRECTOR
References: