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

Study Overview
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Brief Summary
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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%.

Official Title
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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)

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: NCX 470 0.065% (initial phase of trial)
* Drug: Latanoprost 0.005% (initial phase of trial)
* Drug: NCX 470 0.1% (initial phase of trial)
* Drug: NCX 470 0.1% (remainder of trial)
* Drug: Latanoprost 0.005% (remainder of trial)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction from baseline IOP in the study eye | 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 | 3 months | 

Secondary Outcome Measures

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