Phase 2 Dose-Response Study Evaluating the Safety and Efficacy 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. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Official Title
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A Phase 2, Randomized, Multicenter, Masked, Parrallel-Group, Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 (3 Doses: 0.021%, 0.042%, and 0.065%) vs. Latanoprost 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma, Open-Angle, Hypertension, Ocular

Intervention / Treatment
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* Drug: NCX 470
* 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 throughout the day at 2 visits following washout of IOP-lowering medication, if applicable Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye Ability to provide informed consent and follow study instructions Exclusion Criteria: Pigmentary or pseudoexfoliative glaucoma 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: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NCX 470 0.021%<br>NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks | Drug: NCX 470<br>* NCX 470 Ophthalmic Solution<br>|
| Experimental: NCX 470 0.042%<br>NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks | Drug: NCX 470<br>* NCX 470 Ophthalmic Solution<br>|
| Experimental: NCX 470 0.065%<br>NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks | Drug: NCX 470<br>* NCX 470 Ophthalmic Solution<br>|
| Active Comparator: Latanoprost 0.005%<br>Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks | Drug: Latanoprost 0.005%<br>* Latanoprost 0.005% Ophthalmic Solution<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 in Study Eye Mean Diurnal IOP at the Week 4 | Participants used medication in both eyes for 4 weeks with one eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP at week 4 is the average of the 8AM, 10AM and 4PM IOPs at week 4. | Baseline, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Study Eye Mean Diurnal IOP at Week 1, Week 2, and Exit Visit | Participants used medication in both eyes from baseline to the evening prior to the week 4 visit. One eye was designated the study eye at baseline. The study eye was defined as the eye with the highest mean diurnal intraocular pressure (IOP) value at baseline (or the right eye if both eyes had the same IOP value at baseline). Mean diurnal IOP is the average of the 8AM, 10AM and 4PM values. Visits were conducted at week 1, week 2, week 4, and an exit visit (1 to 2 days following the week 4 visit) | Baseline, week 1, week 2, exit visit | 
| Percentage of Subjects With Treatment-emergent Ocular Adverse Events | Safety and tolerability based on percentage of subjects with treatment-emergent ocular adverse events | 4 weeks for adverse events and through 30 days post-treatment for serious adverse events |