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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05451329
Other study ID # VVN539-CS-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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