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
• Disposition First Submitted QC: 2022-09-21
• Disposition First Posted: 2022-09-28
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

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

Read More

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

Read More

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
Reduction from baseline IOP in the study eye	3 months	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

Name	Time	Method
Frequency and incidence of treatment-emergent adverse events	3 months
Rate of discontinuation	3 months
Reduction from baseline in diurnal IOP in the study eye	3 months	Mean diurnal IOP reduction from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye

Trial Locations

Locations (1)

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