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%
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
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
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
No
Data Monitoring Committee
No
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
No
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
Email
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
No
Learn more about this trial
MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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