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

Phase 3

Completed

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

• Registration Number: NCT04445519
• Lead Sponsor: Nicox Ophthalmics, Inc.

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-22
• Study First Posted: 2020-06-24
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Disposition First Submitted: 2022-09-21
• Results First Submitted: 2024-09-19
• Status Verified: 2025-03
• Results First Submitted QC: 2025-05-12
• Results First Posted: 2025-05-30
• Disposition First Posted: 2025-05-30
• Last Update Submitted: 2025-06-06
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 691

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCX 470 0.1%	NCX 470 0.1% (initial phase of trial)	NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes (initial phase of trial)
Latanoprost 0.005% (remainder of trial)	Latanoprost 0.005% (remainder of trial)	Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (active comparator for remainder of trial)
Latanoprost 0.005%	Latanoprost 0.005% (initial phase of trial)	Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes (initial phase of trial)
NCX 470 0.1% (remainder of trial)	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)
NCX 470 0.065%	NCX 470 0.065% (initial phase of trial)	NCX 470 Ophthalmic Solution, 0.065% dosed once daily to both eyes (initial phase of trial)

Primary Outcome Measures

Name	Time	Method
Mean IOP Reduction From Time-Matched Baseline at the 8AM and 4PM Time-Points at Week 2, Week 6, and Month 3	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
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	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).
Number of Subjects With Treatment Emergent Adverse Events (TEAE) by Treatment Group in the Safety Population	3 months	Safety and tolerability based on number subjects with treatment emergent ocular adverse events.
Rate of Discontinuation	3 months	Number of subjects discontinued from the study.

Trial Locations

Locations (1)

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States