Phase 3
Completed N=691
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT04445519 ↗Enrolled (actual)
691
Serious AEs
1.0%
Results posted
May 2025
Primary outcomePrimary: Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3 — -9.43; -8.85; -8.01; -7.11 mmHg
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3 |
-9.43; -8.85; -8.01; -7.11; -9.69; -9.33 | — |
| SECONDARY Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye |
-8.82; -8.05; -9.01; -8.34; -8.90; -8.41 | — |
| SECONDARY Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population |
13; 113; 58; 1; 37; 32 | — |
| SECONDARY Rate of Discontinuation |
3; 14; 17 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
- Qualifying best-corrected visual acuity in each eye
- Ability to provide informed consent and follow study instructions
Exclusion Criteria
- Narrow anterior chamber angles or disqualifying corneal thickness in either eye
- Clinically significant ocular disease in either eye
- Previous complicated surgery or certain types of glaucoma surgery in either eye
- Incisional ocular surgery or severe trauma in either eye within the past 6 months
- Uncontrolled systemic disease
Data sourced from ClinicalTrials.gov (NCT04445519). 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.