Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

Completed · Phase 3

Conditions studied: Open-angle Glaucoma, Ocular Hypertension

In brief

To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%

Key facts

Study ID

NCT02674854

Run by

Aerie Pharmaceuticals

People needed

750

Starts

2016-02-01

Expected to finish

2017-03-01

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older (19 years of age or older in Canada)
• Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
• Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
• Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
• Able to give informed consent and follow study instructions

You may not qualify if…

• Ophthalmic:
• Clinically significant ocular disease
• Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
• Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
• Known hypersensitivity to any component of the formulation or latanoprost
• Previous glaucoma surgery or refractive surgery
• Ocular trauma within 6 months prior to screening
• Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
• Recent or current ocular infection or inflammation in either eye
• Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
• Mean central corneal thickness >620µm at screening in either eye
• Any abnormality preventing reliable applanation tonometry of either eye
• Systemic:
• Clinically significant abnormalities in lab tests at screening
• Clinically significant systemic disease
• Participation in any investigational study within 60 days prior to screening
• Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
• Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control

Where it is running

• Aerie Pharmaceuticals — Bedminster, New Jersey, United States

Full record on ClinicalTrials.gov

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