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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04630808

Acronym

Denali

Enrollment

696

Registered

2020-11-16

Start date

2020-11-09

Completion date

2025-06-25

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Angle Glaucoma, Ocular Hypertension

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.

Interventions

DRUGNCX 470 0.1%

NCX 470 Ophthalmic Solution, 0.1%

DRUGLatanoprost 0.005%

Latanoprost Ophthalmic Solution, 0.005%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

double-masked

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline IOP	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

Secondary

Measure	Time frame	Description
Change from baseline in diurnal IOP	Up to 3 months	Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
Frequency and incidence of treatment-emergent adverse events	12 months	Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events
Rate of discontinuation	12 months	Percentage of subjects in each treatment group who discontinue study participation

Countries

China, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026