Clinical trial NCT02057575: Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure
Official title: A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open Angle Glaucoma
Ocular Hypertension
Keywords: Open Angle Glaucoma
Ocular Hypertension
Intraocular Pressure
AR13324
PG324
Lead sponsor: Aerie Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-02-07
Enrollment: 298
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: To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater.
* Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
* Corrected visual acuity in each eye equivalent to 20/200 or better
* Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

Ophthalmic:

* Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
* Intraocular pressure \>36 mmHg
* Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
* Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
* Refractive surgery in study eye(s)
* Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
* Evidence of ocular infection and inflammation
* Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
* Central corneal thickness greater then 600 μm
* Any abnormality preventing reliable applanation tonometry of either eye

Systemic:

* Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
* Clinically significant systemic disease
* Participation in any investigational study within 30 days prior to screening
* Changes in systemic medication
* Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Study treatment was administered for 28 days, and outcome measures collected on Day 29
Secondary outcomes:
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: 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: Saint Louis
country: United States
facility: Comprehensive Eye Care
state: Missouri
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: 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: Austin
country: United States
facility: Texan Eye
state: Texas
city: Dallas
country: United States
facility: Glaucoma Associates of Texas - Dallas Office
state: Texas
city: El Paso
country: United States
facility: Cataract & Glaucoma Center
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology 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:
affiliation: Aerie Pharmaceuticals, Inc.
name: Nancy Ramirez, M.S.
role: STUDY_DIRECTOR
References:
citation: Lewis RA, Levy B, Ramirez N, Kopczynski CC, Usner DW, Novack GD; PG324-CS201 Study Group. Fixed-dose combination of AR-13324 and latanoprost: a double-masked, 28-day, randomised, controlled study in patients with open-angle glaucoma or ocular hypertension. Br J Ophthalmol. 2016 Mar;100(3):339-44. doi: 10.1136/bjophthalmol-2015-306778. Epub 2015 Jul 24.