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

September 4, 2025 updated by: Nicox Ophthalmics, Inc.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

696

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100005
        • Nicox Clinical Site
      • Beijing, China, 100191
        • Nicox Clinical Site
      • Chongqing, China, 400020
        • Nicox Clinical Site
      • Shanghai, China, 200011
        • Nicox Clinical Site
      • Shanghai, China, 200031
        • Nicox Clinical Site
      • Shanghai, China, 200040
        • Nicox Clinical Site
      • Tianjing, China, 300020
        • Nicox Clinical Site
      • Tianjing, China, 300384
        • Nicox Clinical Site
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Nicox Clinical Site
    • Guangdong
      • Shantou, Guangdong, China, 515401
        • Nicox Clinical Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Nicox Clinical Site
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Nicox Clinical Site
      • Zhengzhou, Henan, China, 450052
        • Nicox Clinical Site
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Nicox Clinical Site
      • Yichang, Hubei, China, 443003
        • Nicox Clinical Site
    • Huna
      • Changsha, Huna, China, 410015
        • Nicox Clinical Site
    • Hunan
      • Changsha, Hunan, China, 410011
        • Nicox Clinical Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Nicox Clinical Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Nicox Clinical Site
    • Liaoning
      • Dalian, Liaoning, China, 116091
        • Nicox Clinical Site
    • Shaanxi
      • Xi'an, Shaanxi, China, 710004
        • Nicox Clinical Site
    • Shandong
      • Jinan, Shandong, China, 250002
        • Nicox Clinical Site
      • Qingdao, Shandong, China, 266071
        • Nicox Clinical Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Nicox Clinical Site
    • Xhejiang
      • Wenzhou, Xhejiang, China, 325027
        • Nicox Clinical Site
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Nicox Clinical Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Nicox Clinical Site
      • Phoenix, Arizona, United States, 85003
        • Nicox Clinical Site
    • California
      • Burbank, California, United States, 91505
        • Nicox Clinical Site
      • Garden Grove, California, United States, 92843
        • Nicox Clinical Site
      • Huntington Beach, California, United States, 92647
        • Nicox Clinical Site
      • La Jolla, California, United States, 92037
        • Nicox Clinical Site
      • Murrieta, California, United States, 92562
        • Nicox Clinical Site
      • Newport Beach, California, United States, 92663
        • Nicox Clinical Site
      • Pasadena, California, United States, 91107
        • Nicox Clinical Site
      • Petaluma, California, United States, 94954
        • Nicox Clinical Site
      • Redlands, California, United States, 92373
        • Nicox Clinical Site
      • San Francisco, California, United States, 94115
        • Nicox Clinical Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Nicox Clinical Site
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Nicox Clinical Site
      • Delray Beach, Florida, United States, 33484
        • Nicox Clinical Site
      • Fort Lauderdale, Florida, United States, 33309
        • Nicox Clinical Site
      • Fort Myers, Florida, United States, 33901
        • Nicox Clinical Site
      • Jacksonville, Florida, United States, 32256
        • Nicox Clinical Site
      • Jupiter, Florida, United States, 33477
        • Nicox Clinical Site
      • Lakeland, Florida, United States, 33805
        • Nicox Clinical Site
      • Largo, Florida, United States, 33770
        • Nicox Clinical Site
      • Mt. Dora, Florida, United States, 32757
        • Nicox Clinical Site
      • Venice, Florida, United States, 34285
        • Nicox Clinical Site
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Nicox Clinical Site
      • Roswell, Georgia, United States, 30076
        • Nicox Clinical Site
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Nicox Clinical Site
      • Rock Island, Illinois, United States, 61201
        • Nicox Clinical Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Nicox Clinical Site
    • Maine
      • Bangor, Maine, United States, 04401
        • Nicox Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Nicox Clinical Site
      • Lancaster, Massachusetts, United States, 01523
        • Nicox Clinical Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Nicox Clinical Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Nicox Clinical Site
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Nicox Clinical Site
      • St Louis, Missouri, United States, 63128
        • Nicox Clinical Site
    • New York
      • Clifton Park, New York, United States, 12065
        • Nicox Clinical Site
      • The Bronx, New York, United States, 10467
        • Nicox Clinical Site
      • Troy, New York, United States, 12180
        • Nicox Clinical Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Nicox Clinical Site
      • Winston-Salem, North Carolina, United States, 27101
        • Nicox Clinical Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Nicox Clinical Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Nicox Clinical Site
      • Cincinnati, Ohio, United States, 45242
        • Nicox Clinical Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Nicox Clinical Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Nicox Clinical Site
      • Kingston, Pennsylvania, United States, 18704
        • Nicox Clinical Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Nicox Clinical Site
      • Memphis, Tennessee, United States, 38120
        • Nicox Clinical Site
    • Texas
      • Austin, Texas, United States, 78731
        • Nicox Clinical Site
      • El Paso, Texas, United States, 79922
        • Nicox Clinical Site
      • Houston, Texas, United States, 77008
        • Nicox Clinical Site
      • Houston, Texas, United States, 77025
        • Nicox Clinical Site
      • Mission, Texas, United States, 78572
        • Nicox Clinical Site
      • San Antonio, Texas, United States, 78212
        • Nicox Clinical Site
      • San Antonio, Texas, United States, 78229
        • Nicox Clinical Site
      • San Antonio, Texas, United States, 78238
        • Nicox Clinical Site
      • Sugar Land, Texas, United States, 77479
        • Nicox Clinical Site
    • Utah
      • St. George, Utah, United States, 84790
        • Nicox Clinical Site
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Nicox Clinical Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Nicox Clinical Site
      • Seattle, Washington, United States, 98104
        • Nicox Clinical Site
      • Seattle, Washington, United States, 98125
        • Nicox Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
Drug: NCX 470 0.1%
NCX 470 Ophthalmic Solution, 0.1%
Other Names:
  • NCX 470
Active Comparator: Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes
Drug: Latanoprost 0.005%
Latanoprost Ophthalmic Solution, 0.005%
Other Names:
  • Latanoprost

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 months
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
12 months
Rate of discontinuation
Time Frame: 12 months
Percentage of subjects in each treatment group who discontinue study participation
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicox Ophthalmics, Inc.

Investigators

  • Study Director: Nicox Ophthalmics, Nicox Ophthalmics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Actual)

April 11, 2025

Study Completion (Actual)

June 25, 2025

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCX-470-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ocular Hypertension

Clinical Trials on NCX 470 0.1%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe