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

NCT ID: NCT05451329

Last Updated: 2024-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2022-12-22

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VVN539 Ophthalmic Solution 0.02%

VVN539 Ophthalmic Solution 0.02%

Group Type: ACTIVE_COMPARATOR

VVN539 Ophthalmic Solution 0.02%

Intervention Type: DRUG

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

VVN539 Ophthalmic Solution 0.04%

VVN539 Ophthalmic Solution 0.04%

Group Type: ACTIVE_COMPARATOR

VVN539 Ophthalmic Solution 0.04%

Intervention Type: DRUG

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

VVN539 Ophthalmic Solution Vehicle

VVN539 Ophthalmic Solution Vehicle

Group Type: PLACEBO_COMPARATOR

VVN539 Ophthalmic Solution Vehicle

Intervention Type: DRUG

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

Interventions

VVN539 Ophthalmic Solution 0.02%

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

Intervention Type: DRUG

VVN539 Ophthalmic Solution 0.04%

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

Intervention Type: DRUG

VVN539 Ophthalmic Solution Vehicle

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VivaVision Biotech, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao-Yan Li, M.D.

Role: STUDY_DIRECTOR

VivaVision

Locations

Lexitas

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VVN539-CS-201

Identifier Type: -

Identifier Source: org_study_id