Study Assessing Safety and Efficacy of PG324 Ophthalmic Solution in Patients With Elevated Intraocular Pressure

Completed · Phase 2

Conditions studied: Open Angle Glaucoma, Ocular Hypertension

In brief

To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.

Key facts

Study ID

NCT02057575

Run by

Aerie Pharmaceuticals

People needed

298

Starts

2014-01-01

Expected to finish

2014-06-01

Last updated by the study team

2019-06-04

Who can join

Age: 18 and older. 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)
• Corrected visual acuity in each eye equivalent to 20/200 or better
• 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.
• 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.

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
• Bacharach practice — 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
• Seidenberg Protzko Eye Associates — Havre de Grace, Maryland, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• Comprehensive Eye Care — St Louis, Missouri, United States
• Ophthalmic Consultants of Long Island — Lynbrook, New York, United States
• Rochester Ophthalmological Group — Rochester, New York, United States
• Charlotte Eye Ear Nose & Throat Associates, P.A. — Belmont, North Carolina, United States
• Michael E. Tepedino, M.D. — High Point, North Carolina, United States
• The Eye Institute — Tulsa, Oklahoma, United States
• Texan Eye — Austin, Texas, United States
• Glaucoma Associates of Texas - Dallas Office — Dallas, Texas, United States
• Cataract & Glaucoma Center — El Paso, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Stacy R. Smith, M.D. — Salt Lake City, Utah, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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