NCT05451329

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: VivaVision Biotech, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-07-12
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2022-07-11
• Last updated: 2024-01-17
• Results posted: 2024-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study