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

NCT05451329 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-01-17

Study results available
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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

Interventions

DRUG

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

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

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

Sponsors & Collaborators

  • VivaVision Biotech, Inc

    lead INDUSTRY

Principal Investigators

  • Xiao-Yan Li, M.D. · VivaVision

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-12
Primary Completion
2022-12-22
Completion
2022-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05451329 on ClinicalTrials.gov