MRCT Evaluating 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 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.

Official Title
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A Phase 3, Randomized, Multi-Regional, Double-Masked, Parallel-Group Trial Evaluating the Safety and Efficacy of NCX 470 0.1% vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension (Denali)

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: NCX 470 0.1%
* Drug: Latanoprost 0.005%


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 0.1%<br>NCX 470 Ophthalmic Solution, 0.1% dosed once daily to both eyes | Drug: NCX 470 0.1%<br>* NCX 470 Ophthalmic Solution, 0.1%<br>* Other names: NCX 470;|
| Active Comparator: Latanoprost 0.005%<br>Latanoprost Ophthalmic Solution, 0.005% dosed once daily to both eyes | Drug: Latanoprost 0.005%<br>* Latanoprost Ophthalmic Solution, 0.005%<br>* Other names: Latanoprost;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline IOP | 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 | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in diurnal IOP | Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye | Up to 3 months | 
| Frequency and incidence of treatment-emergent adverse events | Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events | 12 months | 
| Rate of discontinuation | Percentage of subjects in each treatment group who discontinue study participation | 12 months |