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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02057575
• Other study ID #: PG324-CS201
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: June 2014

Study information

• Verified date: May 2019
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• PG324 Ophthalmic Solution 0.01%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
• PG324 Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
• Netarsudil (AR-13324) Ophthalmic Solution 0.02%
1 drop in the evening (PM), once daily (QD), both eyes (OU)
• Latanoprost Ophthalmic Solution 0.005%
1 drop in the evening (PM), once daily (QD), both eyes (OU)

Locations

Country	Name	City	State
United States	Kenneth Sall, M.D.	Artesia	California
United States	Texan Eye	Austin	Texas
United States	Charlotte Eye Ear Nose & Throat Associates, P.A.	Belmont	North Carolina
United States	Glaucoma Associates of Texas - Dallas Office	Dallas	Texas
United States	Cataract & Glaucoma Center	El Paso	Texas
United States	Seidenberg Protzko Eye Associates	Havre De Grace	Maryland
United States	Michael E. Tepedino, M.D.	High Point	North Carolina
United States	United Medical Research Institute	Inglewood	California
United States	Taustine Eye Center	Louisville	Kentucky
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Clayton Eye Center	Morrow	Georgia
United States	Aesthetic Eye Care Institute	Newport Beach	California
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Bacharach practice	Petaluma	California
United States	Centre For Health Care	Poway	California
United States	Rochester Ophthalmological Group	Rochester	New York
United States	Coastal Research Associates, LLC	Roswell	Georgia
United States	Great Lakes Eye Care	Saint Joseph	Michigan
United States	Comprehensive Eye Care	Saint Louis	Missouri
United States	Stacy R. Smith, M.D.	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Bradley Kwapiszeski, MD	Shawnee Mission	Kansas
United States	The Eye Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.	Study treatment was administered for 28 days, and outcome measures collected on Day 29