Phase 3
Completed N=718
Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT02558400 ↗Enrolled (actual)
718
Serious AEs
3.5%
Results posted
Jun 2019
Primary outcomePrimary: Intraocular Pressure (IOP) — 24.84; 24.81; 24.59; 23.72 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 and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.
Linked Publications
-
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
24.84; 24.81; 24.59; 23.72; 23.45; 23.43 | <0.0001 sig |
| SECONDARY Extent of Exposure |
275.7; 266.2; 330.4 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- Unmedicated intraocular pressure >20mmHg and 620µm at screening
- Any abnormality preventing reliable applanation tonometry of either eye
- Clinically significant abnormalities in lab tests at screening
- Clinically significant systemic disease
- Participation in any investigational study within 60 days prior to screening
- Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
- Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
Data sourced from ClinicalTrials.gov (NCT02558400) 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.