NCT04630808

MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 696 (actual)
• Sponsor: Nicox Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	NCX 470 0.1%	NCX 470 Ophthalmic Solution, 0.1%
DRUG	Latanoprost 0.005%	Latanoprost Ophthalmic Solution, 0.005%

Timeline

• Start date: 2020-11-09
• Primary completion: 2025-04-11
• Completion: 2025-06-25
• First posted: 2020-11-16
• Last updated: 2025-09-08

Locations

88 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study