ClinicalTrials.gg
CompletedNCT04630808DenaliUpdated Sep 8, 2025

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

A Phase 3 interventional study of NCX 470 0.1% and Latanoprost 0.005% in Open Angle Glaucoma and Ocular Hypertension, sponsored by Nicox Ophthalmics, Inc.. Completed at 88 sites in 2 countries. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Nicox Ophthalmics, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2025, 1 year 7 months ago, and no results have been posted to the registry; the sponsor requested a delay in submitting them in Sep 2025.
Phase
Phase 3
Study type
Interventional
Enrollment
696
Allocation
Randomized
Ages
18 Years to 84 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Open Angle Glaucoma
  • Ocular Hypertension
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's enrollment of 696 is above the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Nicox Ophthalmics, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and follow study instructions

Exclusion criteria

Exclusion Criteria:

  • Narrow anterior chamber angles or disqualifying corneal thickness in either eye
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
696 participants (actual)

Study arms

  • Experimental
    NCX 470 0.1%

    NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes

    Drug: NCX 470 0.1%

  • Active comparator
    Latanoprost 0.005%

    Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

    Drug: Latanoprost 0.005%

Interventions

  • NCX 470 Ophthalmic Solution, 0.1%

    Also known as: NCX 470

  • Latanoprost Ophthalmic Solution, 0.005%

    Also known as: Latanoprost

06

What researchers measure

Primary outcomes

  1. Change from baseline IOP

    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

    Time frame: Up to 3 months

Secondary outcomes

  1. Change from baseline in diurnal IOP

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

    Time frame: Up to 3 months

  2. Frequency and incidence of treatment-emergent adverse events

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

    Time frame: 12 months

  3. Rate of discontinuation

    Percentage of subjects in each treatment group who discontinue study participation

    Time frame: 12 months

07

Study locations

88 sites
  • Nicox Clinical Site
    Dothan, Alabama 36301, United States
  • Nicox Clinical Site
    Chandler, Arizona 85224, United States
  • Nicox Clinical Site
    Phoenix, Arizona 85003, United States
  • Nicox Clinical Site
    Burbank, California 91505, United States
  • Nicox Clinical Site
    Garden Grove, California 92843, United States
  • Nicox Clinical Site
    Huntington Beach, California 92647, United States
  • Nicox Clinical Site
    La Jolla, California 92037, United States
  • Nicox Clinical Site
    Murrieta, California 92562, United States
  • Nicox Clinical Site
    Newport Beach, California 92663, United States
  • Nicox Clinical Site
    Pasadena, California 91107, United States
  • Nicox Clinical Site
    Petaluma, California 94954, United States
  • Nicox Clinical Site
    Redlands, California 92373, United States
  • Nicox Clinical Site
    San Francisco, California 94115, United States
  • Nicox Clinical Site
    Danbury, Connecticut 06810, United States
  • Nicox Clinical Site
    Boynton Beach, Florida 33437, United States
  • Nicox Clinical Site
    Delray Beach, Florida 33484, United States
  • Nicox Clinical Site
    Fort Lauderdale, Florida 33309, United States
  • Nicox Clinical Site
    Fort Myers, Florida 33901, United States
  • Nicox Clinical Site
    Jacksonville, Florida 32256, United States
  • Nicox Clinical Site
    Jupiter, Florida 33477, United States
  • Nicox Clinical Site
    Lakeland, Florida 33805, United States
  • Nicox Clinical Site
    Largo, Florida 33770, United States
  • Nicox Clinical Site
    Mt. Dora, Florida 32757, United States
  • Nicox Clinical Site
    Venice, Florida 34285, United States
  • Nicox Clinical Site
    Morrow, Georgia 30260, United States
  • Nicox Clinical Site
    Roswell, Georgia 30076, United States
  • Nicox Clinical Site
    Peoria, Illinois 61615, United States
  • Nicox Clinical Site
    Rock Island, Illinois 61201, United States
  • Nicox Clinical Site
    Indianapolis, Indiana 46202, United States
  • Nicox Clinical Site
    Bangor, Maine 04401, United States
  • Nicox Clinical Site
    Boston, Massachusetts 02114, United States
  • Nicox Clinical Site
    Lancaster, Massachusetts 01523, United States
  • Nicox Clinical Site
    Grand Rapids, Michigan 49546, United States
  • Nicox Clinical Site
    Chaska, Minnesota 55318, United States
  • Nicox Clinical Site
    Kansas City, Missouri 64111, United States
  • Nicox Clinical Site
    St Louis, Missouri 63128, United States
  • Nicox Clinical Site
    Clifton Park, New York 12065, United States
  • Nicox Clinical Site
    The Bronx, New York 10467, United States
  • Nicox Clinical Site
    Troy, New York 12180, United States
  • Nicox Clinical Site
    Asheville, North Carolina 28803, United States
  • Nicox Clinical Site
    Winston-Salem, North Carolina 27101, United States
  • Nicox Clinical Site
    Fargo, North Dakota 58103, United States
  • Nicox Clinical Site
    Cincinnati, Ohio 45236, United States
  • Nicox Clinical Site
    Cincinnati, Ohio 45242, United States
  • Nicox Clinical Site
    Eugene, Oregon 97401, United States
  • Nicox Clinical Site
    Cranberry Township, Pennsylvania 16066, United States
  • Nicox Clinical Site
    Kingston, Pennsylvania 18704, United States
  • Nicox Clinical Site
    Memphis, Tennessee 38119, United States
  • Nicox Clinical Site
    Memphis, Tennessee 38120, United States
  • Nicox Clinical Site
    Austin, Texas 78731, United States
  • Nicox Clinical Site
    El Paso, Texas 79922, United States
  • Nicox Clinical Site
    Houston, Texas 77008, United States
  • Nicox Clinical Site
    Houston, Texas 77025, United States
  • Nicox Clinical Site
    Mission, Texas 78572, United States
  • Nicox Clinical Site
    San Antonio, Texas 78212, United States
  • Nicox Clinical Site
    San Antonio, Texas 78229, United States
  • Nicox Clinical Site
    San Antonio, Texas 78238, United States
  • Nicox Clinical Site
    Sugar Land, Texas 77479, United States
  • Nicox Clinical Site
    St. George, Utah 84790, United States
  • Nicox Clinical Site
    Falls Church, Virginia 22042, United States
  • Nicox Clinical Site
    Bellevue, Washington 98004, United States
  • Nicox Clinical Site
    Seattle, Washington 98104, United States
  • Nicox Clinical Site
    Seattle, Washington 98125, United States
  • Nicox Clinical Site
    Lanzhou, Gansu 730030, China
  • Nicox Clinical Site
    Shantou, Guangdong 515401, China
  • Nicox Clinical Site
    Harbin, Heilongjiang 150086, China
  • Nicox Clinical Site
    Zhengzhou, Henan 450003, China
  • Nicox Clinical Site
    Zhengzhou, Henan 450052, China
  • Nicox Clinical Site
    Wuhan, Hubei 430060, China
  • Nicox Clinical Site
    Yichang, Hubei 443003, China
  • Nicox Clinical Site
    Changsha, Hunan 410011, China
  • Nicox Clinical Site
    Changsha, Huna 410015, China
  • Nicox Clinical Site
    Nanchang, Jiangxi 330006, China
  • Nicox Clinical Site
    Changchun, Jilin 130021, China
  • Nicox Clinical Site
    Dalian, Liaoning 116091, China
  • Nicox Clinical Site
    Xi'an, Shaanxi 710004, China
  • Nicox Clinical Site
    Jinan, Shandong 250002, China
  • Nicox Clinical Site
    Qingdao, Shandong 266071, China
  • Nicox Clinical Site
    Chengdu, Sichuan 610041, China
  • Nicox Clinical Site
    Wenzhou, Xhejiang 325027, China
  • Nicox Clinical Site
    Beijing, 100005, China
  • Nicox Clinical Site
    Beijing, 100191, China
  • Nicox Clinical Site
    Chongqing, 400020, China
  • Nicox Clinical Site
    Shanghai, 200011, China
  • Nicox Clinical Site
    Shanghai, 200031, China
  • Nicox Clinical Site
    Shanghai, 200040, China
  • Nicox Clinical Site
    Tianjing, 300020, China
  • Nicox Clinical Site
    Tianjing, 300384, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04630808
Lead sponsor
Nicox Ophthalmics, Inc.
Responsible party
Sponsor
First posted
Nov 16, 2020
Start date
Nov 9, 2020
Primary completion
Apr 11, 2025
Completion
Jun 25, 2025
Last update
Sep 8, 2025

Study contacts

Nicox Ophthalmics
study director · Nicox Ophthalmics, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: NCX 470

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