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

NCT ID: NCT04630808

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2025-06-25

Brief Summary

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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.

Detailed Description

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Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
double-masked

Study Groups

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NCX 470 0.1%

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

Group Type EXPERIMENTAL

NCX 470 0.1%

Intervention Type DRUG

NCX 470 Ophthalmic Solution, 0.1%

Latanoprost 0.005%

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

Group Type ACTIVE_COMPARATOR

Latanoprost 0.005%

Intervention Type DRUG

Latanoprost Ophthalmic Solution, 0.005%

Interventions

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NCX 470 0.1%

NCX 470 Ophthalmic Solution, 0.1%

Intervention Type DRUG

Latanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005%

Intervention Type DRUG

Other Intervention Names

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NCX 470 Latanoprost

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicox Ophthalmics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicox Ophthalmics

Role: STUDY_DIRECTOR

Nicox Ophthalmics, Inc.

Locations

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Nicox Clinical Site

Dothan, Alabama, United States

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Chandler, Arizona, United States

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Phoenix, Arizona, United States

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Burbank, California, United States

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Garden Grove, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Murrieta, California, United States

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Newport Beach, California, United States

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Pasadena, California, United States

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Petaluma, California, United States

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Redlands, California, United States

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San Francisco, California, United States

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Danbury, Connecticut, United States

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Boynton Beach, Florida, United States

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Delray Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Jacksonville, Florida, United States

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Jupiter, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Mt. Dora, Florida, United States

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Venice, Florida, United States

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Morrow, Georgia, United States

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Roswell, Georgia, United States

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Peoria, Illinois, United States

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Rock Island, Illinois, United States

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Indianapolis, Indiana, United States

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Bangor, Maine, United States

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Boston, Massachusetts, United States

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Lancaster, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Chaska, Minnesota, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Clifton Park, New York, United States

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The Bronx, New York, United States

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Troy, New York, United States

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Asheville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Eugene, Oregon, United States

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Cranberry Township, Pennsylvania, United States

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Kingston, Pennsylvania, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Mission, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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St. George, Utah, United States

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Falls Church, Virginia, United States

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Bellevue, Washington, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Lanzhou, Gansu, China

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Shantou, Guangdong, China

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Harbin, Heilongjiang, China

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Zhengzhou, Henan, China

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Zhengzhou, Henan, China

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Wuhan, Hubei, China

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Yichang, Hubei, China

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Changsha, Hunan, China

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Changsha, Huna, China

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Nanchang, Jiangxi, China

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Changchun, Jilin, China

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Dalian, Liaoning, China

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Xi'an, Shaanxi, China

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Jinan, Shandong, China

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Qingdao, Shandong, China

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Chengdu, Sichuan, China

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Wenzhou, Xhejiang, China

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Beijing, , China

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Beijing, , China

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Chongqing, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Tianjing, , China

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Tianjing, , China

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Countries

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United States China

Other Identifiers

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NCX-470-03

Identifier Type: -

Identifier Source: org_study_id

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