NCT04445519

Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 691 (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 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%.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	NCX 470 0.065% (initial phase of trial)	NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
DRUG	Latanoprost 0.005% (initial phase of trial)	Latanoprost Ophthalmic Solution, 0.005%
DRUG	NCX 470 0.1% (initial phase of trial)	NCX 470 Ophthalmic Solution, 0.1%
DRUG	NCX 470 0.1% (remainder of trial)	NCX 470 Ophthalmic Solution, 0.1%
DRUG	Latanoprost 0.005% (remainder of trial)	Latanoprost Ophthalmic Solution, 0.005%

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-09-16
• Completion: 2022-09-16
• First posted: 2020-06-24
• Last updated: 2025-06-24
• Results posted: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study