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

Glaucoma, Open-Angle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05451329
• Other study ID #: VVN539-CS-201
• Status: Completed
• Phase: Phase 2
• Start date: July 12, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: December 2023
• Source: VivaVision Biotech, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	Lexitas	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VivaVision Biotech, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure	mmHg	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Secondary	Mean Change in Intraocular Pressure From Baseline	mmHg	8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21