Clinical trial NCT04630808: MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-16
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline IOP
timeFrame: Up to 3 months
Secondary outcomes:
measure: Change from baseline in diurnal IOP
timeFrame: Up to 3 months
measure: Frequency and incidence of treatment-emergent adverse events
timeFrame: 12 months
measure: Rate of discontinuation
timeFrame: 12 months
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Nicox Clinical Site
state: Alabama
city: Chandler
country: United States
facility: Nicox Clinical Site
state: Arizona
city: Phoenix
country: United States
facility: Nicox Clinical Site
state: Arizona
city: Burbank
country: United States
facility: Nicox Clinical Site
state: California
city: Garden Grove
country: United States
facility: Nicox Clinical Site
state: California
city: Huntington Beach
country: United States
facility: Nicox Clinical Site
state: California
city: La Jolla
country: United States
facility: Nicox Clinical Site
state: California
city: Murrieta
country: United States
facility: Nicox Clinical Site
state: California
city: Newport Beach
country: United States
facility: Nicox Clinical Site
state: California
city: Pasadena
country: United States
facility: Nicox Clinical Site
state: California
city: Petaluma
country: United States
facility: Nicox Clinical Site
state: California
city: Redlands
country: United States
facility: Nicox Clinical Site
state: California
city: San Francisco
country: United States
facility: Nicox Clinical Site
state: California
city: Danbury
country: United States
facility: Nicox Clinical Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Nicox Clinical Site
state: Florida
city: Delray Beach
country: United States
facility: Nicox Clinical Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Nicox Clinical Site
state: Florida
city: Fort Myers
country: United States
facility: Nicox Clinical Site
state: Florida
city: Jacksonville
country: United States
facility: Nicox Clinical Site
state: Florida
city: Jupiter
country: United States
facility: Nicox Clinical Site
state: Florida
city: Lakeland
country: United States
facility: Nicox Clinical Site
state: Florida
city: Largo
country: United States
facility: Nicox Clinical Site
state: Florida
city: Mount Dora
country: United States
facility: Nicox Clinical Site
state: Florida
city: Venice
country: United States
facility: Nicox Clinical Site
state: Florida
city: Morrow
country: United States
facility: Nicox Clinical Site
state: Georgia
city: Roswell
country: United States
facility: Nicox Clinical Site
state: Georgia
city: Peoria
country: United States
facility: Nicox Clinical Site
state: Illinois
city: Rock Island
country: United States
facility: Nicox Clinical Site
state: Illinois
city: Indianapolis
country: United States
facility: Nicox Clinical Site
state: Indiana
city: Bangor
country: United States
facility: Nicox Clinical Site
state: Maine
city: Boston
country: United States
facility: Nicox Clinical Site
state: Massachusetts
city: Lancaster
country: United States
facility: Nicox Clinical Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Nicox Clinical Site
state: Michigan
city: Chaska
country: United States
facility: Nicox Clinical Site
state: Minnesota
city: Kansas City
country: United States
facility: Nicox Clinical Site
state: Missouri
city: Saint Louis
country: United States
facility: Nicox Clinical Site
state: Missouri
city: Bronx
country: United States
facility: Nicox Clinical Site
state: New York
city: Clifton Park
country: United States
facility: Nicox Clinical Site
state: New York
city: Troy
country: United States
facility: Nicox Clinical Site
state: New York
city: Asheville
country: United States
facility: Nicox Clinical Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Nicox Clinical Site
state: North Carolina
city: Fargo
country: United States
facility: Nicox Clinical Site
state: North Dakota
city: Cincinnati
country: United States
facility: Nicox Clinical Site
state: Ohio
city: Cincinnati
country: United States
facility: Nicox Clinical Site
state: Ohio
city: Eugene
country: United States
facility: Nicox Clinical Site
state: Oregon
city: Cranberry Township
country: United States
facility: Nicox Clinical Site
state: Pennsylvania
city: Kingston
country: United States
facility: Nicox Clinical Site
state: Pennsylvania
city: Memphis
country: United States
facility: Nicox Clinical Site
state: Tennessee
city: Memphis
country: United States
facility: Nicox Clinical Site
state: Tennessee
city: Austin
country: United States
facility: Nicox Clinical Site
state: Texas
city: El Paso
country: United States
facility: Nicox Clinical Site
state: Texas
city: Houston
country: United States
facility: Nicox Clinical Site
state: Texas
city: Houston
country: United States
facility: Nicox Clinical Site
state: Texas
city: Mission
country: United States
facility: Nicox Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Nicox Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Nicox Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Nicox Clinical Site
state: Texas
city: Sugar Land
country: United States
facility: Nicox Clinical Site
state: Texas
city: Saint George
country: United States
facility: Nicox Clinical Site
state: Utah
city: Falls Church
country: United States
facility: Nicox Clinical Site
state: Virginia
city: Bellevue
country: United States
facility: Nicox Clinical Site
state: Washington
city: Seattle
country: United States
facility: Nicox Clinical Site
state: Washington
city: Seattle
country: United States
facility: Nicox Clinical Site
state: Washington
city: Lanzhou
country: China
facility: Nicox Clinical Site
state: Gansu
city: Shantou
country: China
facility: Nicox Clinical Site
state: Guangdong
city: Harbin
country: China
facility: Nicox Clinical Site
state: Heilongjiang
city: Zhengzhou
country: China
facility: Nicox Clinical Site
state: Henan
city: Zhengzhou
country: China
facility: Nicox Clinical Site
state: Henan
city: Wuhan
country: China
facility: Nicox Clinical Site
state: Hubei
city: Yichang
country: China
facility: Nicox Clinical Site
state: Hubei
city: Changsha
country: China
facility: Nicox Clinical Site
state: Hunan
city: Changsha
country: China
facility: Nicox Clinical Site
state: Huna
city: Nanchang
country: China
facility: Nicox Clinical Site
state: Jiangxi
city: Changchun
country: China
facility: Nicox Clinical Site
state: Jilin
city: Dalian
country: China
facility: Nicox Clinical Site
state: Liaoning
city: Xi'an
country: China
facility: Nicox Clinical Site
state: Shaanxi
city: Jinan
country: China
facility: Nicox Clinical Site
state: Shandong
city: Qingdao
country: China
facility: Nicox Clinical Site
state: Shandong
city: Chengdu
country: China
facility: Nicox Clinical Site
state: Sichuan
city: Wenzhou
country: China
facility: Nicox Clinical Site
state: Xhejiang
city: Beijing
country: China
facility: Nicox Clinical Site
city: Beijing
country: China
facility: Nicox Clinical Site
city: Chongqing
country: China
facility: Nicox Clinical Site
city: Shanghai
country: China
facility: Nicox Clinical Site
city: Shanghai
country: China
facility: Nicox Clinical Site
city: Shanghai
country: China
facility: Nicox Clinical Site
city: Tianjing
country: China
facility: Nicox Clinical Site
city: Tianjing
country: China
facility: Nicox Clinical Site
Study officials:
affiliation: Nicox Ophthalmics, Inc.
name: Nicox Ophthalmics
role: STUDY_DIRECTOR
References: