A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure

Study Overview
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Brief Summary
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This is a prospective, parallel-comparison, multi-center, double-masked, randomized, vehicle-controlled dose-response study assessing the safety and ocular hypotensive efficacy of VVN539 in subjects with POAG or OHT. Three different dosing regimens (once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days, each.

Official Title
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A Phase 2, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of VVN539 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Drug: VVN539 Ophthalmic Solution 0.02%
* Drug: VVN539 Ophthalmic Solution 0.04%
* Drug: VVN539 Ophthalmic Solution Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes that are untreated, or if treated, in the opinion of the investigator are well controlled on 2 or fewer ocular hypotensive medications prior to Visit 1. Unmedicated intraocular pressure of ≥ 22 mm Hg and ≤ 36 mm Hg in the study eye, with no more than 5 mm Hg inter-eye difference at 08:00AM and 10:00AM at Visit 2. Corrected visual acuity in each eye +1.0 or better by Early Treatment Diabetic Retinopathy Scale in each eye (equivalent to Snellen 20/200) Exclusion Criteria: Known hypersensitivity to any kinase inhibitors, any excipient or preservative of the formulation or to topical anesthetics or fluorescein. Unmedicated IOP of > 36 mm Hg in either eye at any time point at Visit 2.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Double-masked, randomized, parallel
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VVN539 Ophthalmic Solution 0.02%<br>VVN539 Ophthalmic Solution 0.02% | Drug: VVN539 Ophthalmic Solution 0.02%<br>* Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days<br>|
| Active Comparator: VVN539 Ophthalmic Solution 0.04%<br>VVN539 Ophthalmic Solution 0.04% | Drug: VVN539 Ophthalmic Solution 0.04%<br>* Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days<br>|
| Placebo Comparator: VVN539 Ophthalmic Solution Vehicle<br>VVN539 Ophthalmic Solution Vehicle | Drug: VVN539 Ophthalmic Solution Vehicle<br>* Once a day [q.d.] in the morning, q.d. in the evening and twice a day [b.i.d.]) will be tested for 7-9 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in intraocular pressure from baseline | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 | 
| Safety - Adverse event | Incidence of Adverse Events | Day 21 |