Phase 3 N=750 Randomized Double-blind Treatment

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

Open-angle Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02674854 ↗

Enrolled (actual)

750

Serious AEs

1.7%

Results posted

May 2019

Primary outcome: Primary: Intraocular Pressure (IOP) — 24.69; 24.66; 24.75; 23.33 mmHg — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: PG324 Ophthalmic Solution 0.02%/0.005% (Drug); Netarsudil (AR-13324) ophthalmic solution 0.02% (Drug); Latanoprost ophthalmic solution 0.005% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aerie Pharmaceuticals
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Intraocular Pressure (IOP)	24.69; 24.66; 24.75; 23.33; 23.40; 23.23	<0.0001 sig

Summary

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%

Eligibility Criteria

Inclusion Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02674854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.