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

VivaVision Biotech

Status and phase: Completed; Phase 2

Conditions: Glaucoma, Open-Angle

Treatments: Drug: VVN539 Ophthalmic Solution 0.04%; Drug: VVN539 Ophthalmic Solution 0.02%; Drug: VVN539 Ophthalmic Solution Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05451329

VVN539-CS-201

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 3 patient groups, including a placebo group

VVN539 Ophthalmic Solution 0.02%

Active Comparator group

Description:

VVN539 Ophthalmic Solution 0.02%

Treatment:

Drug: VVN539 Ophthalmic Solution 0.02%

VVN539 Ophthalmic Solution 0.04%

Active Comparator group

Description:

VVN539 Ophthalmic Solution 0.04%

Treatment:

Drug: VVN539 Ophthalmic Solution 0.04%

VVN539 Ophthalmic Solution Vehicle

Placebo Comparator group

Description:

VVN539 Ophthalmic Solution Vehicle

Treatment:

Drug: VVN539 Ophthalmic Solution Vehicle