Phase 2
N=68
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Glaucoma, Open-Angle
Bottom Line
View on ClinicalTrials.gov: NCT05451329 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Mean Intraocular Pressure — 21.8; 20.5; 23.4; 19.7 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VVN539 Ophthalmic Solution 0.02% (Drug); VVN539 Ophthalmic Solution 0.04% (Drug); VVN539 Ophthalmic Solution Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VivaVision Biotech, Inc
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Intraocular Pressure |
21.8; 20.5; 23.4; 19.7; 19.0; 22.0 | — |
| SECONDARY Mean Change in Intraocular Pressure From Baseline |
-3.6; -4.1; -2.0; -5.3; -5.0; -2.3 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05451329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.