MRCT Evaluating NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Phase 3

Active, not recruiting

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: NCX 470 0.1%; Drug: Latanoprost 0.005%

• Registration Number: NCT04630808
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-09
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-16
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-03
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 696

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCX 470 0.1%	NCX 470 0.1%	NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes
Latanoprost 0.005%	Latanoprost 0.005%	Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes

Primary Outcome Measures

Name	Time	Method
Change from baseline IOP	Up to 3 months	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

Name	Time	Method
Change from baseline in diurnal IOP	Up to 3 months	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	12 months	Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events
Rate of discontinuation	12 months	Percentage of subjects in each treatment group who discontinue study participation

Trial Locations

Locations (1)

Nicox Clinical Site; 🇨🇳 Tianjing, China