drugset / Trial / NCT04630808
MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
RandomizedParallel-groupDouble-blindTreatment
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 subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
Timeline
- Start
- 2020-11-09
- Primary completion
- 2025-04-11
- Completion
- 2025-06-25
Outcome
Met primary endpoint
release “Nicox Reports Achieving Primary Objective in Mont Blanc, the First Phase 3 Glaucoma Trial for NCX 470” nicox.com ↗
release “The Denali phase 3 clinical trial met its primary endpoint of demonstrating non-inferiority of NCX 470 0.1% to latanoprost 0.005% at every time point.” nicox.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Latanoprost | Small molecule | 0.005 % | — |
| Subject | NCX 470 | Unknown | 0.1 % | — |