Skip to main content
OpenTrials
Completed

NCT Number: NCT04630808

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nicox Clinical Site, Lanzhou, Gansu, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
  • Qualifying IOP at 3 time points through the day at 2 visits following washout of IOP-lowering medication, if applicable
  • Qualifying best-corrected visual acuity in each eye
  • Ability to provide informed consent and follow study instructions

Exclusion criteria

  • Narrow anterior chamber angles or disqualifying corneal thickness in either eye
  • Clinically significant ocular disease in either eye
  • Previous complicated surgery or certain types of glaucoma surgery in either eye
  • Incisional ocular surgery or severe trauma in either eye within the past 6 months
  • Uncontrolled systemic disease

Treatment and study plan

NCX 470 0.1%

Drug

NCX 470 Ophthalmic Solution, 0.1%

Other names: NCX 470

Latanoprost 0.005%

Drug

Latanoprost Ophthalmic Solution, 0.005%

Other names: Latanoprost

Primary outcomes

  1. Change from baseline IOP

    Time frame: Up to 3 months

    Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye

Secondary outcomes

  1. Change from baseline in diurnal IOP

    Time frame: Up to 3 months

    Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye

  2. Frequency and incidence of treatment-emergent adverse events

    Time frame: 12 months

    Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events

  3. Rate of discontinuation

    Time frame: 12 months

    Percentage of subjects in each treatment group who discontinue study participation

Sponsors and collaborators

Lead sponsor

Nicox Ophthalmics, Inc.

Industry

Registry information

Official study title

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)

Acronym: Denali

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2020
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.