Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Mont Blanc)

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)

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%.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: NCX 470 0.065% (initial phase of trial); Drug: NCX 470 0.1% (initial phase of trial); Drug: Latanoprost 0.005% (initial phase of trial); Drug: NCX 470 0.1% (remainder of trial); Drug: Latanoprost 0.005% (remainder of trial)

• Study Type: Interventional
• Enrollment (Actual): 691
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NCX 470 0.065%; NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)	Drug: NCX 470 0.065% (initial phase of trial); NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)
Experimental: NCX 470 0.1%; NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)	Drug: NCX 470 0.1% (initial phase of trial); NCX 470 Ophthalmic Solution, 0.1%
Active Comparator: Latanoprost 0.005%; Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)	Drug: Latanoprost 0.005% (initial phase of trial); Latanoprost Ophthalmic Solution, 0.005%; Other Names: Latanoprost
Experimental: NCX 470 0.1% (remainder 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)	Drug: NCX 470 0.1% (remainder of trial); NCX 470 Ophthalmic Solution, 0.1%
Active Comparator: Latanoprost 0.005% (remainder of trial); Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)	Drug: Latanoprost 0.005% (remainder of trial); Latanoprost Ophthalmic Solution, 0.005%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3	The analysis performed as part of the Adaptive Dose Phase of the study was to evaluate the efficacy and safety of both concentrations of NCX 470 compared to Latanoprost. The primary endpoint for the interim analysis was mean diurnal IOP. Subsequent to the interim analysis at Week 2, the NCX 470 0.065% arm was discontinued and the primary analysis only included NCX 470 0.1% vs Latanoprost. The primary efficacy outcome results are reported for the NCX 470 0.1% and Latanoprost 0.005% treatment groups at Week 2, Week 6, and Month 3. As prespecified in the Statistical Analysis Plan, mean change from baseline in time-matched IOP was not calculated for the 0.065% group. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline). The fellow eye was followed for safety.	Baseline, Week 2, Week 6, and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye	Subjects in the NCX 470 0.065% treatment group were discontinued at Week 2 based upon the results of the planned, interim analysis. Subjects in the NCX 470 0.1% and Latanoprost 0.005% treatment groups continued for 3 months. Participants used medication in both eyes for 3 months with 1 eye designated as study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or right eye if both eyes had the same IOP value at baseline).	Baseline, Week 2, Week 6, and Month 3
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population	Safety and tolerability based on number subjects with treatment emergent ocular adverse events.	3 months
Rate of Discontinuation	Number of subjects discontinued from the study.	3 months

Collaborators and Investigators

• Sponsor: Nicox Ophthalmics, Inc.
• Investigators: Study Director: Nicox Ophthalmics, Inc., Nicox Ophthalmics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 16, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: June 19, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Hypertension; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: NCX-470-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No