Phase 3
Completed N=430
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT03284853 ↗Enrolled (actual)
430
Serious AEs
3.3%
Results posted
Jan 2022
Primary outcomePrimary: Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry — 15.39; 15.56; 15.64; 15.25 mmHg — p=<0.05
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study is intended to test the effectiveness and safety of Netarsudil / Latanoprost 0.02% / 0.005% Ophthalmic Solution, relative to GANFORT® for lowering of intraocular pressure (IOP) in patients with elevated intraocular pressure
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal Intraocular Pressure by Goldmann Applanation Tonometry |
15.39; 15.56; 15.64; 15.25; 15.61; 15.19 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- Must be 18 years of age or older.
- Diagnosis of OAG or OHT in both eyes (OAG in one eye and OHT in the fellow eye is acceptable).
- Subjects insufficiently controlled and/or subjects considered in need for combination therapy by the investigators.
- Medicated intraocular pressure ≥ 17 mmHg in at least one eye and 20mmHg in at least one eye and 17mmHg in at least one eye and 45 years in the absence of HRT. In questionable cases the subject must have FSH value > 40mIU/mL and an estradiol value < 40pg/mL (< 140pmol/L)) or three months post-surgical sterilization.
- Vulnerable subjects such as minors, adults under legal protection or unable to express their consent (e.g. hospitalized persons in coma), persons deprived of liberty (prisoners from jails), or persons subject to psychiatric care.
Data sourced from ClinicalTrials.gov (NCT03284853). 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.