Clinical trial NCT01789736: A Study Assessing PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components for 28 Days
Official title: A Study Assessing the Safety and Ocular Hypotensive Efficacy of PG286 Ophthalmic Solution, 0.5% Compared to Its Individual Components
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular hypertension
AR-12286
Travoprost
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 234
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: In the double-masked, randomized, multi-center, active-controlled parallel study, patients will be randomized to receive either a fixed dose combination of AR-12286 and travoprost, AR-12286, or travoprost. The hypothesis is that there is no difference between each treatment arm.


Eligibility criteria: Subject inclusion criteria

1. 18 years of age or greater.
2. Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT).
3. Unmedicated (post-washout) IOP ≥ 22 mm Hg at 2 qualification visits (08:00 hr), 2-7 days apart. At second qualification visit, IOP \>21 mmHg at 10:00 and 16:00 hrs.
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.

Subject exclusion criteria

Excluded from the study will be individuals with the following characteristics:

Ophthalmic (in either eye):

1. Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles. Note: Previous laser peripheral iridotomy is NOT acceptable.
2. Intraocular pressure \> 35 mm Hg, or use of more than two ocular hypotensive medications within 30 days of screening. Note: fixed dose combinations count as two medications.
3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, zinc, etc.), travoprost, 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 six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
7. Evidence of ocular infection, inflammation, clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis at screening.
8. Ocular medication of any kind within 30 days of screening, 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 screening) or c) lubricating drops for dry eye (which may be used throughout the study).
9. 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., 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 investigator) in laboratory tests at screening.
13. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
14. Participation in any investigational study within 30 days prior to screening.
15. Changes of systemic medication within 30 days prior to screening, or anticipated during the study, that could have a substantial effect on IOP.
16. 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: Mean diurnal IOP
timeFrame: 28 Days
Secondary outcomes:
measure: IOP
timeFrame: 7-28 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: Bacharach practice
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: St Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Bronx
country: United States
facility: Jeffrey Schultz, M.D.
state: New York
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: Belmont
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, P.A.
state: North Carolina
city: Tulsa
country: United States
facility: The Eye Institute
state: Oklahoma
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophth. Associates
state: Texas
city: Salt Lake City
country: United States
facility: Stacy R. Smith, M.D.
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References: