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

NCT04445519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 691

Last updated 2025-06-24

Study results available
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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

Interventions

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%

Sponsors & Collaborators

  • Nicox Ophthalmics, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicox Ophthalmics, Inc. · Nicox Ophthalmics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-09-16
Completion
2022-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445519 on ClinicalTrials.gov