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

Phase 2

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Netarsudil (AR-13324) Ophthalmic Solution 0.02%; Drug: PG324 Ophthalmic Solution 0.01%; Drug: Latanoprost Ophthalmic Solution 0.005%; Drug: PG324 Ophthalmic Solution 0.02%

• Registration Number: NCT02057575
• Lead Sponsor: Aerie Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-07
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Disposition First Submitted: 2015-07-09
• Disposition First Submitted QC: 2015-07-09
• Disposition First Posted: 2015-07-31
• Results First Submitted: 2019-03-27
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Results First Posted: 2019-06-04
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil (AR-13324) Ophthalmic Solution 0.02%	Netarsudil (AR-13324) Ophthalmic Solution 0.02%	Netarsudil 0.02% ophthalmic solution
PG324 Ophthalmic Solution 0.01%	PG324 Ophthalmic Solution 0.01%	Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
Latanoprost Ophthalmic Solution 0.005%	Latanoprost Ophthalmic Solution 0.005%	Latanoprost 0.005% ophthalmic solution
PG324 Ophthalmic Solution 0.02%	PG324 Ophthalmic Solution 0.02%	Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	Study treatment was administered for 28 days, and outcome measures collected on Day 29	The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.

Trial Locations

Locations (23)

Comprehensive Eye Care; 🇺🇸 Saint Louis, Missouri, United States

Stacy R. Smith, M.D.; 🇺🇸 Salt Lake City, Utah, United States

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

Taustine Eye Center; 🇺🇸 Louisville, Kentucky, 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

The Eye Institute; 🇺🇸 Tulsa, Oklahoma, United States

Michael E. Tepedino, M.D.; 🇺🇸 High Point, North Carolina, United States

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Bradley Kwapiszeski, MD; 🇺🇸 Shawnee Mission, Kansas, United States

Texan Eye; 🇺🇸 Austin, Texas, United States

Seidenberg Protzko Eye Associates; 🇺🇸 Havre De Grace, Maryland, United States

Great Lakes Eye Care; 🇺🇸 Saint Joseph, Michigan, United States

Glaucoma Associates of Texas - Dallas Office; 🇺🇸 Dallas, Texas, United States

Cataract & Glaucoma Center; 🇺🇸 El Paso, Texas, United States