Back to resultsPhase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NCX 470 0.065% (initial phase of trial)
Latanoprost 0.005% (initial phase of trial)
NCX 470 0.1% (initial phase of trial)
NCX 470 0.1% (remainder of trial)
Latanoprost 0.005% (remainder of trial)
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 Foundation
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
NCX 470 0.065%
NCX 470 0.1%
Latanoprost 0.005%
NCX 470 0.1% (remainder of trial)
Latanoprost 0.005% (remainder of trial)
Arm Description
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
Outcomes
Primary Outcome Measures
Reduction from baseline IOP in the study eye
Mean IOP reduction 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
Reduction from baseline in diurnal IOP in the study eye
Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
Frequency and incidence of treatment-emergent adverse events
Rate of discontinuation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04445519
Brief Title
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Acronym
Mont Blanc
Official Title
Phase 3, Randomized, Adaptive Dose-Selection, Multi-regional, Double-Masked, Parallel-Group, 3-Month Trial Evaluating the Safety and Efficacy of NCX 470 vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
September 16, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
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
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 patients with ocular hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial, subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%) or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
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 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NCX 470 0.065%
Arm Type
Experimental
Arm Description
NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)
Arm Title
NCX 470 0.1%
Arm Type
Experimental
Arm Description
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
Arm Title
Latanoprost 0.005%
Arm Type
Active Comparator
Arm Description
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
Arm Title
NCX 470 0.1% (remainder of trial)
Arm Type
Experimental
Arm Description
NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (chosen dose of NCX 470 to continue in remainder of trial)
Arm Title
Latanoprost 0.005% (remainder of trial)
Arm Type
Active Comparator
Arm Description
Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
Intervention Type
Drug
Intervention Name(s)
NCX 470 0.065% (initial phase of trial)
Intervention Description
NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% (initial phase of trial)
Other Intervention Name(s)
Latanoprost
Intervention Description
Latanoprost Ophthalmic Solution, 0.005%
Intervention Type
Drug
Intervention Name(s)
NCX 470 0.1% (initial phase of trial)
Intervention Description
NCX 470 Ophthalmic Solution, 0.1%
Intervention Type
Drug
Intervention Name(s)
NCX 470 0.1% (remainder of trial)
Intervention Description
NCX 470 Ophthalmic Solution, 0.1%
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% (remainder of trial)
Intervention Description
Latanoprost Ophthalmic Solution, 0.005%
Primary Outcome Measure Information:
Title
Reduction from baseline IOP in the study eye
Description
Mean IOP reduction 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
3 months
Secondary Outcome Measure Information:
Title
Reduction from baseline in diurnal IOP in the study eye
Description
Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
Time Frame
3 months
Title
Frequency and incidence of treatment-emergent adverse events
Time Frame
3 months
Title
Rate of discontinuation
Time Frame
3 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicox Ophthalmics, Inc.
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
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