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

NCT04630808 | Completed Phase 3 FDA Drug

• 1 other identifier: NCX-470-03
• Study Type: interventional
• Target: 696
• Locations: 2 countries
• Sites: 88

Brief 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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

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

  Up to 3 months

Secondary Outcomes (3)

• Change from baseline in diurnal IOP

  Up to 3 months

• Frequency and incidence of treatment-emergent adverse events

  12 months

• Rate of discontinuation

  12 months

Study Arms (2)

NCX 470 0.1%

EXPERIMENTAL

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

Drug: NCX 470 0.1%

Latanoprost 0.005%

ACTIVE COMPARATOR

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

Drug: Latanoprost 0.005%

Interventions

NCX 470 0.1% DRUG

NCX 470 Ophthalmic Solution, 0.1%

Also known as: NCX 470

NCX 470 0.1%

Latanoprost 0.005% DRUG

Latanoprost Ophthalmic Solution, 0.005%

Also known as: Latanoprost

Latanoprost 0.005%

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicox Ophthalmics, Inc.: lead

Study Sites (88)

Nicox Clinical Site

Dothan, Alabama, 36301, United States

Location

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Chandler, Arizona, 85224, United States

Location

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Phoenix, Arizona, 85003, United States

Location

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Burbank, California, 91505, United States

Location

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Garden Grove, California, 92843, United States

Location

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Huntington Beach, California, 92647, United States

Location

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La Jolla, California, 92037, United States

Location

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Murrieta, California, 92562, United States

Location

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Newport Beach, California, 92663, United States

Location

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Pasadena, California, 91107, United States

Location

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Petaluma, California, 94954, United States

Location

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Redlands, California, 92373, United States

Location

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San Francisco, California, 94115, United States

Location

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Danbury, Connecticut, 06810, United States

Location

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Boynton Beach, Florida, 33437, United States

Location

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Delray Beach, Florida, 33484, United States

Location

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Fort Lauderdale, Florida, 33309, United States

Location

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Fort Myers, Florida, 33901, United States

Location

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Jacksonville, Florida, 32256, United States

Location

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Jupiter, Florida, 33477, United States

Location

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Lakeland, Florida, 33805, United States

Location

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Largo, Florida, 33770, United States

Location

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Mt. Dora, Florida, 32757, United States

Location

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Venice, Florida, 34285, United States

Location

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Morrow, Georgia, 30260, United States

Location

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Roswell, Georgia, 30076, United States

Location

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Peoria, Illinois, 61615, United States

Location

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Rock Island, Illinois, 61201, United States

Location

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Indianapolis, Indiana, 46202, United States

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Bangor, Maine, 04401, United States

Location

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Boston, Massachusetts, 02114, United States

Location

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Lancaster, Massachusetts, 01523, United States

Location

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Grand Rapids, Michigan, 49546, United States

Location

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Chaska, Minnesota, 55318, United States

Location

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Kansas City, Missouri, 64111, United States

Location

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St Louis, Missouri, 63128, United States

Location

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Clifton Park, New York, 12065, United States

Location

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The Bronx, New York, 10467, United States

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Troy, New York, 12180, United States

Location

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Asheville, North Carolina, 28803, United States

Location

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Winston-Salem, North Carolina, 27101, United States

Location

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Fargo, North Dakota, 58103, United States

Location

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Cincinnati, Ohio, 45236, United States

Location

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Cincinnati, Ohio, 45242, United States

Location

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Eugene, Oregon, 97401, United States

Location

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Cranberry Township, Pennsylvania, 16066, United States

Location

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Kingston, Pennsylvania, 18704, United States

Location

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Memphis, Tennessee, 38119, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Austin, Texas, 78731, United States

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El Paso, Texas, 79922, United States

Location

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Houston, Texas, 77008, United States

Location

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Houston, Texas, 77025, United States

Location

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Mission, Texas, 78572, United States

Location

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San Antonio, Texas, 78212, United States

Location

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San Antonio, Texas, 78229, United States

Location

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San Antonio, Texas, 78238, United States

Location

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Sugar Land, Texas, 77479, United States

Location

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St. George, Utah, 84790, United States

Location

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Falls Church, Virginia, 22042, United States

Location

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Bellevue, Washington, 98004, United States

Location

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Seattle, Washington, 98104, United States

Location

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Seattle, Washington, 98125, United States

Location

Nicox Clinical Site

Lanzhou, Gansu, 730030, China

Location

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Shantou, Guangdong, 515401, China

Location

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Harbin, Heilongjiang, 150086, China

Location

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Zhengzhou, Henan, 450003, China

Location

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Zhengzhou, Henan, 450052, China

Location

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Wuhan, Hubei, 430060, China

Location

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Yichang, Hubei, 443003, China

Location

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Changsha, Hunan, 410011, China

Location

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Changsha, Huna, 410015, China

Location

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Nanchang, Jiangxi, 330006, China

Location

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Changchun, Jilin, 130021, China

Location

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Dalian, Liaoning, 116091, China

Location

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Xi'an, Shaanxi, 710004, China

Location

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Jinan, Shandong, 250002, China

Location

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Qingdao, Shandong, 266071, China

Location

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Chengdu, Sichuan, 610041, China

Location

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Wenzhou, Xhejiang, 325027, China

Location

Nicox Clinical Site

Beijing, 100005, China

Location

Nicox Clinical Site

Beijing, 100191, China

Location

Nicox Clinical Site

Chongqing, 400020, China

Location

Nicox Clinical Site

Shanghai, 200011, China

Location

Nicox Clinical Site

Shanghai, 200031, China

Location

Nicox Clinical Site

Shanghai, 200040, China

Location

Nicox Clinical Site

Tianjing, 300020, China

Location

Nicox Clinical Site

Tianjing, 300384, China

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Nicox Ophthalmics

  Nicox Ophthalmics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 16, 2020
• Study Start: November 9, 2020
• Primary Completion: April 11, 2025
• Study Completion: June 25, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25); US (63)