NCT03657797

Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 656 (actual)
• Sponsor: Nicox Ophthalmics, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Conditions

• Glaucoma, Open-Angle
• Hypertension, Ocular

Interventions

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

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-08-23
• Completion: 2019-08-23
• First posted: 2018-09-05
• Last updated: 2023-06-18
• Results posted: 2022-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study