NCT05451329CompletedPhase 2
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
VivaVision Biotech, Inc1 site in 1 country68 target enrollmentStarted: July 12, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Mean Intraocular Pressure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple masking
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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.
Arms & Interventions
VVN539 Ophthalmic Solution 0.02%
Active Comparator
VVN539 Ophthalmic Solution 0.02%
Intervention: VVN539 Ophthalmic Solution 0.02% (Drug)
VVN539 Ophthalmic Solution 0.04%
Active Comparator
VVN539 Ophthalmic Solution 0.04%
Intervention: VVN539 Ophthalmic Solution 0.04% (Drug)
VVN539 Ophthalmic Solution Vehicle
Placebo Comparator
VVN539 Ophthalmic Solution Vehicle
Intervention: VVN539 Ophthalmic Solution Vehicle (Drug)
Outcomes
Primary Outcomes
Mean Intraocular Pressure
Time Frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
mmHg
Secondary Outcomes
- Mean Change in Intraocular Pressure From Baseline(8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21)
Investigators
Study Sites (1)
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