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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status

Recruiting

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

NCX 470 0.1%

Latanoprost 0.005%

About this trial

This is an interventional treatment trial for Open Angle Glaucoma

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Eye Research FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NCX 470 0.1%

Latanoprost 0.005%

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Frequency and incidence of treatment-emergent adverse events

Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events

Rate of discontinuation

Percentage of subjects in each treatment group who discontinue study participation

Full Information

NCT ID

NCT04630808

First Posted

November 11, 2020

Last Updated

June 15, 2023

Sponsor

Nicox Ophthalmics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04630808

Brief Title

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

Acronym

Denali

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 9, 2020 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nicox Ophthalmics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

double-masked

Allocation

Randomized

Enrollment

670 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NCX 470 0.1%

Arm Type

Experimental

Arm Description

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

Arm Title

Latanoprost 0.005%

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

NCX 470 0.1%

Other Intervention Name(s)

NCX 470

Intervention Description

NCX 470 Ophthalmic Solution, 0.1%

Intervention Type

Drug

Intervention Name(s)

Latanoprost 0.005%

Other Intervention Name(s)

Latanoprost

Intervention Description

Latanoprost Ophthalmic Solution, 0.005%

Primary Outcome Measure Information:

Title

Change from baseline IOP

Description

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

Time Frame

Up to 3 months

Secondary Outcome Measure Information:

Title

Change from baseline in diurnal IOP

Description

Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye

Time Frame

Up to 3 months

Title

Frequency and incidence of treatment-emergent adverse events

Description

Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events

Time Frame

12 months

Title

Rate of discontinuation

Description

Percentage of subjects in each treatment group who discontinue study participation

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

84 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicox Ophthalmics

Phone

984-219-1715

First Name & Middle Initial & Last Name or Official Title & Degree

Siobhan Garbutt, PhD

Phone

984-219-1715

NCX470@nicox.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicox Ophthalmics

Organizational Affiliation

Nicox Ophthalmics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Eye Research Foundation

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Linda Wirta

Phone

949-650-1863

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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