Open Angle GlaucomaPhase 3DenaliNCT04630808
MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing NCX 470 0.1% and Latanoprost 0.005% in people with Open Angle Glaucoma and Ocular Hypertension, run by Nicox Ophthalmics, Inc. at 88 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- NCX 470 0.1% and Latanoprost 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 88 sitesin 2 countries
- Study dates
- 9 Nov 2020to 25 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
88 sites in 2 countries.
88 sites in 2 countries
United States63 sites
Nicox Clinical Site
Asheville, North Carolina, 28803
Nicox Clinical Site
Austin, Texas, 78731
Nicox Clinical Site
Bangor, Maine, 04401
Nicox Clinical Site
Bellevue, Washington, 98004
Nicox Clinical Site
Boston, Massachusetts, 02114
Nicox Clinical Site
Boynton Beach, Florida, 33437
Nicox Clinical Site
Burbank, California, 91505
Nicox Clinical Site
Chandler, Arizona, 85224
Nicox Clinical Site
Chaska, Minnesota, 55318
Nicox Clinical Site
Cincinnati, Ohio, 45236
Nicox Clinical Site
Cincinnati, Ohio, 45242
Nicox Clinical Site
Clifton Park, New York, 12065
Nicox Clinical Site
Cranberry Township, Pennsylvania, 16066
Nicox Clinical Site
Danbury, Connecticut, 06810
Nicox Clinical Site
Delray Beach, Florida, 33484
Nicox Clinical Site
Dothan, Alabama, 36301
Nicox Clinical Site
El Paso, Texas, 79922
Nicox Clinical Site
Eugene, Oregon, 97401
Nicox Clinical Site
Falls Church, Virginia, 22042
Nicox Clinical Site
Fargo, North Dakota, 58103
Nicox Clinical Site
Fort Lauderdale, Florida, 33309
Nicox Clinical Site
Fort Myers, Florida, 33901
Nicox Clinical Site
Garden Grove, California, 92843
Nicox Clinical Site
Grand Rapids, Michigan, 49546
Nicox Clinical Site
Houston, Texas, 77008
Nicox Clinical Site
Houston, Texas, 77025
Nicox Clinical Site
Huntington Beach, California, 92647
Nicox Clinical Site
Indianapolis, Indiana, 46202
Nicox Clinical Site
Jacksonville, Florida, 32256
Nicox Clinical Site
Jupiter, Florida, 33477
Nicox Clinical Site
Kansas City, Missouri, 64111
Nicox Clinical Site
Kingston, Pennsylvania, 18704
Nicox Clinical Site
La Jolla, California, 92037
Nicox Clinical Site
Lakeland, Florida, 33805
Nicox Clinical Site
Lancaster, Massachusetts, 01523
Nicox Clinical Site
Largo, Florida, 33770
Nicox Clinical Site
Memphis, Tennessee, 38119
Nicox Clinical Site
Memphis, Tennessee, 38120
Nicox Clinical Site
Mission, Texas, 78572
Nicox Clinical Site
Morrow, Georgia, 30260
Nicox Clinical Site
Mt. Dora, Florida, 32757
Nicox Clinical Site
Murrieta, California, 92562
Nicox Clinical Site
Newport Beach, California, 92663
Nicox Clinical Site
Pasadena, California, 91107
Nicox Clinical Site
Peoria, Illinois, 61615
Nicox Clinical Site
Petaluma, California, 94954
Nicox Clinical Site
Phoenix, Arizona, 85003
Nicox Clinical Site
Redlands, California, 92373
Nicox Clinical Site
Rock Island, Illinois, 61201
Nicox Clinical Site
Roswell, Georgia, 30076
Nicox Clinical Site
San Antonio, Texas, 78212
Nicox Clinical Site
San Antonio, Texas, 78229
Nicox Clinical Site
San Antonio, Texas, 78238
Nicox Clinical Site
San Francisco, California, 94115
Nicox Clinical Site
Seattle, Washington, 98104
Nicox Clinical Site
Seattle, Washington, 98125
Nicox Clinical Site
St Louis, Missouri, 63128
Nicox Clinical Site
St. George, Utah, 84790
Nicox Clinical Site
Sugar Land, Texas, 77479
Nicox Clinical Site
The Bronx, New York, 10467
Nicox Clinical Site
Troy, New York, 12180
Nicox Clinical Site
Venice, Florida, 34285
Nicox Clinical Site
Winston-Salem, North Carolina, 27101
China25 sites
Nicox Clinical Site
Beijing, 100005
Nicox Clinical Site
Beijing, 100191
Nicox Clinical Site
Changchun, Jilin, 130021
Nicox Clinical Site
Changsha, Hunan, 410011
Nicox Clinical Site
Changsha, Huna, 410015
Nicox Clinical Site
Chengdu, Sichuan, 610041
Nicox Clinical Site
Chongqing, 400020
Nicox Clinical Site
Dalian, Liaoning, 116091
Nicox Clinical Site
Harbin, Heilongjiang, 150086
Nicox Clinical Site
Jinan, Shandong, 250002
Nicox Clinical Site
Lanzhou, Gansu, 730030
Nicox Clinical Site
Nanchang, Jiangxi, 330006
Nicox Clinical Site
Qingdao, Shandong, 266071
Nicox Clinical Site
Shanghai, 200011
Nicox Clinical Site
Shanghai, 200031
Nicox Clinical Site
Shanghai, 200040
Nicox Clinical Site
Shantou, Guangdong, 515401
Nicox Clinical Site
Tianjing, 300020
Nicox Clinical Site
Tianjing, 300384
Nicox Clinical Site
Wenzhou, Xhejiang, 325027
Nicox Clinical Site
Wuhan, Hubei, 430060
Nicox Clinical Site
Xi'an, Shaanxi, 710004
Nicox Clinical Site
Yichang, Hubei, 443003
Nicox Clinical Site
Zhengzhou, Henan, 450003
Nicox Clinical Site
Zhengzhou, Henan, 450052
About this study
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)
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
- Being tested
- NCX 470 0.1%, Latanoprost 0.005%
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCX 470 0.1%Drug
Also called NCX 470
NCX 470 Ophthalmic Solution, 0.1%
Latanoprost 0.005%Drug
Also called Latanoprost
Latanoprost Ophthalmic Solution, 0.005%
| Study group | Role | What they receive |
|---|---|---|
| NCX 470 0.1% | Experimental | NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes Receives: Drug: NCX 470 0.1% |
| Latanoprost 0.005% | Active comparator | Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes Receives: Drug: Latanoprost 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 months
Secondary outcomes (3)
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
Measured: Up to 3 months
Frequency and incidence of treatment-emergent adverse events
Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events
Measured: 12 months
Rate of discontinuation
Percentage of subjects in each treatment group who discontinue study participation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start9 Nov 2020
- Primary completion11 Apr 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicox Ophthalmics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicox Ophthalmics, Study director, Nicox Ophthalmics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630808
- Sponsor's protocol ID
- NCX-470-03
- Acronym
- Denali
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2020
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04630808
- Acronym / sponsor ID
- Denali / NCX-470-03
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Nicox Ophthalmics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCX 470 0.1% | Experimental | Drug: NCX 470 0.1%NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes |
| Latanoprost 0.005% | Active comparator | Drug: Latanoprost 0.005%Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCX 470 0.1%Also: NCX 470NCX 470 Ophthalmic Solution, 0.1% | Drug | NCX 470 0.1% |
| Latanoprost 0.005%Also: LatanoprostLatanoprost Ophthalmic Solution, 0.005% | Drug | Latanoprost 0.005% |
Primary outcome
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
3 secondary outcomes
Change from baseline in diurnal IOP
Time frame: Up to 3 months
Frequency and incidence of treatment-emergent adverse events
Time frame: 12 months
Rate of discontinuation
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicox Ophthalmics study director
Nicox Ophthalmics, Inc.
88 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NCX 470 0.1% and Latanoprost 0.005% in people with Open Angle Glaucoma and Ocular Hypertension, run by Nicox Ophthalmics, Inc. at 88 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 88 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline IOP (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.