Phase 3
Completed N=750
Double-masked Study of PG324 Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT02674854 ↗Enrolled (actual)
750
Serious AEs
1.7%
Results posted
May 2019
Primary outcomePrimary: Intraocular Pressure (IOP) — 24.69; 24.66; 24.75; 23.33 mmHg — p=<0.0001
◆ Published Evidence
Established
88citations · ~15 / year
Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2.
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%
Linked Publications (2)
-
Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2.
-
Effects of Netarsudil and Latanoprost Alone and in Fixed Combination on Corneal Endothelium and Corneal Thickness: Post-Hoc Analysis of MERCURY-2.
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 |
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
Data sourced from ClinicalTrials.gov (NCT02674854) and the linked publication. 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. Informational only — not medical advice.