Back to resultsA Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
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.
Sites / Locations
- Lexitas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution Vehicle
Arm Description
VVN539 Ophthalmic Solution 0.02%
VVN539 Ophthalmic Solution 0.04%
VVN539 Ophthalmic Solution Vehicle
Outcomes
Primary Outcome Measures
Mean intraocular pressure
mmHg
Secondary Outcome Measures
Mean change in intraocular pressure from baseline
mmHg
Safety - Adverse event
Incidence of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05451329
Brief Title
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VivaVision Biotech, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-masked, randomized, parallel
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple masking
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VVN539 Ophthalmic Solution 0.02%
Arm Type
Active Comparator
Arm Description
VVN539 Ophthalmic Solution 0.02%
Arm Title
VVN539 Ophthalmic Solution 0.04%
Arm Type
Active Comparator
Arm Description
VVN539 Ophthalmic Solution 0.04%
Arm Title
VVN539 Ophthalmic Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
VVN539 Ophthalmic Solution Vehicle
Intervention Type
Drug
Intervention Name(s)
VVN539 Ophthalmic Solution 0.02%
Intervention Description
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
Intervention Name(s)
VVN539 Ophthalmic Solution 0.04%
Intervention Description
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
Intervention Name(s)
VVN539 Ophthalmic Solution Vehicle
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean intraocular pressure
Description
mmHg
Time Frame
8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Secondary Outcome Measure Information:
Title
Mean change in intraocular pressure from baseline
Description
mmHg
Time Frame
8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Title
Safety - Adverse event
Description
Incidence of Adverse Events
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-Yan Li, M.D.
Organizational Affiliation
VivaVision
Official's Role
Study Director
Facility Information:
Facility Name
Lexitas
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2 Double-masked Study of VVN539 in Subjects With Elevated Intraocular Pressure
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