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

February 23, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

670

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 Contact

Study Contact Backup

  • Name: Nicox Ophthalmics
  • Phone Number: 984-710-5354

Study Locations

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

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 (Estimated)

June 1, 2025

Study Completion (Estimated)

September 1, 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)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

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.

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