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

NCT04445519 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NCX-470-02
• Study Type: interventional
• Target: 691
• Locations: 1 country
• Sites: 1

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%.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction From Baseline in Mean Diurnal IOP at Week 2, Week 6, and Month 3 in the Study Eye

  Baseline, Week 2, Week 6, and Month 3

• Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population

  3 months

• Rate of Discontinuation

  3 months

Study Arms (5)

NCX 470 0.065%

EXPERIMENTAL

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 0.1%

EXPERIMENTAL

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)

Latanoprost 0.005%

ACTIVE COMPARATOR

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)

Drug: Latanoprost 0.005% (initial phase of trial)

NCX 470 0.1% (remainder of trial)

EXPERIMENTAL

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)

Latanoprost 0.005% (remainder of trial)

ACTIVE COMPARATOR

Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)

Drug: Latanoprost 0.005% (remainder of trial)

Interventions

NCX 470 0.065% (initial phase of trial) DRUG

NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial)

NCX 470 0.065%

Latanoprost 0.005% (initial phase of trial) DRUG

Latanoprost Ophthalmic Solution, 0.005%

Also known as: Latanoprost

Latanoprost 0.005%

NCX 470 0.1% (initial phase of trial) DRUG

NCX 470 Ophthalmic Solution, 0.1%

NCX 470 0.1%

NCX 470 0.1% (remainder of trial) DRUG

NCX 470 Ophthalmic Solution, 0.1%

NCX 470 0.1% (remainder of trial)

Latanoprost 0.005% (remainder of trial) DRUG

Latanoprost Ophthalmic Solution, 0.005%

Latanoprost 0.005% (remainder of trial)

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicox Ophthalmics, Inc.: lead

Study Sites (1)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Limitations and Caveats

This was a robust, international trial demonstrating the safety and efficacy of NCX 470 0.1% Ophthalmic Solution. A 2nd Phase 3 trial is on-going and the sponsor expects the results of the 2nd trial to be consistent with the results of this study. While this study was only 3 months in length, the 2nd trial is a 12-month study.

Results Point of Contact

• Title: Doug Hubatsch/Chief Scientific Officer
• Organization: Nicox Ophthalmics, Inc.

hubatsch@nicox.com

984-710-5354

Study Officials

• Nicox Ophthalmics, Inc.

  Nicox Ophthalmics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: June 1, 2020
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: June 24, 2025
• Results First Posted: May 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)