Glaucoma, Open-Angle
Conditions
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.
Interventions
DRUGVVN539 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
DRUGVVN539 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
DRUGVVN539 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
VivaVision Biotech, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple masking
Intervention model description
Double-masked, randomized, parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intraocular Pressure | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 | mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Intraocular Pressure From Baseline | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 | mmHg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VVN539 Ophthalmic Solution 0.02% VVN539 Ophthalmic Solution 0.02%
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 | 23 |
| VVN539 Ophthalmic Solution 0.04% VVN539 Ophthalmic Solution 0.04%
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 | 22 |
| VVN539 Ophthalmic Solution Vehicle VVN539 Ophthalmic Solution Vehicle
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 | 23 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 |
| Overall Study | Investigational Product Lot exchange | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | VVN539 Ophthalmic Solution 0.02% | VVN539 Ophthalmic Solution 0.04% | VVN539 Ophthalmic Solution Vehicle | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 13 Participants | 14 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 9 Participants | 23 Participants |
| Age, Continuous | 69.1 years STANDARD_DEVIATION 9 | 65.1 years STANDARD_DEVIATION 13.4 | 64.7 years STANDARD_DEVIATION 16.4 | 66.3 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 20 Participants | 20 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 19 Participants | 23 Participants | 60 Participants |
| Region of Enrollment United States | 23 participants | 22 participants | 23 participants | 68 participants |
| Sex: Female, Male Female | 12 Participants | 9 Participants | 12 Participants | 33 Participants |
| Sex: Female, Male Male | 11 Participants | 13 Participants | 11 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 11 / 23 | 10 / 22 | 1 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 | 0 / 23 |
Outcome results
Primary
Mean Intraocular Pressure
mmHg
Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0400 PM Day 14 | 19.7 mmHg | Standard Deviation 5.2 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 1000 AM Day 7 | 19.7 mmHg | Standard Deviation 4.7 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0400 PM Day 7 | 19.1 mmHg | Standard Deviation 4.1 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0400 PM Day 21 | 18.7 mmHg | Standard Deviation 5.2 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0800 AM Day 21 | 19.7 mmHg | Standard Deviation 3.6 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0800 AM Day 14 | 21.1 mmHg | Standard Deviation 5 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 1000 AM Day 21 | 19.2 mmHg | Standard Deviation 5 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 0800 AM Day 7 | 21.8 mmHg | Standard Deviation 4.6 |
| VVN539 Ophthalmic Solution 0.02% | Mean Intraocular Pressure | 1000 AM Day 14 | 19.9 mmHg | Standard Deviation 5.1 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 1000 AM Day 7 | 19.0 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0800 AM Day 7 | 20.5 mmHg | Standard Deviation 2.5 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0800 AM Day 21 | 19.2 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0400 PM Day 21 | 18.8 mmHg | Standard Deviation 3 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 1000 AM Day 14 | 18.2 mmHg | Standard Deviation 4.3 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0400 PM Day 14 | 18.0 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0400 PM Day 7 | 18.1 mmHg | Standard Deviation 2.6 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 1000 AM Day 21 | 19.1 mmHg | Standard Deviation 3.3 |
| VVN539 Ophthalmic Solution 0.04% | Mean Intraocular Pressure | 0800 AM Day 14 | 19.6 mmHg | Standard Deviation 3.9 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0400 PM Day 21 | 21.7 mmHg | Standard Deviation 3.7 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0400 PM Day 14 | 22.0 mmHg | Standard Deviation 3.9 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0800 AM Day 7 | 23.4 mmHg | Standard Deviation 3.9 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 1000 AM Day 7 | 22.0 mmHg | Standard Deviation 3.1 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0400 PM Day 7 | 21.7 mmHg | Standard Deviation 2.9 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0800 AM Day 14 | 23.1 mmHg | Standard Deviation 3.5 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 1000 AM Day 14 | 22.1 mmHg | Standard Deviation 3 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 0800 AM Day 21 | 23.4 mmHg | Standard Deviation 3.9 |
| VVN539 Ophthalmic Solution Vehicle | Mean Intraocular Pressure | 1000 AM Day 21 | 22.6 mmHg | Standard Deviation 3.2 |
Secondary
Mean Change in Intraocular Pressure From Baseline
mmHg
Time frame: 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 14 | -4.3 mmHg | Standard Deviation 4.3 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 21 | -3.7 mmHg | Standard Deviation 4.3 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 14 | -2.7 mmHg | Standard Deviation 4.6 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 1000 PM Day 14 | -5.1 mmHg | Standard Deviation 4.2 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 7 | -3.6 mmHg | Standard Deviation 4.1 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 21 | -5.7 mmHg | Standard Deviation 3.9 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 7 | -3.3 mmHg | Standard Deviation 3.5 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 7 | -5.3 mmHg | Standard Deviation 4.2 |
| VVN539 Ophthalmic Solution 0.02% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 21 | -5.7 mmHg | Standard Deviation 2.7 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 1000 PM Day 14 | -5.8 mmHg | Standard Deviation 3.6 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 7 | -4.1 mmHg | Standard Deviation 2.7 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 7 | -5.0 mmHg | Standard Deviation 3 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 7 | -4.6 mmHg | Standard Deviation 2.6 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 14 | -5.0 mmHg | Standard Deviation 4 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 14 | -4.8 mmHg | Standard Deviation 3.3 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 21 | -5.4 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 21 | -5.0 mmHg | Standard Deviation 3.7 |
| VVN539 Ophthalmic Solution 0.04% | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 21 | -3.9 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 7 | -1.3 mmHg | Standard Deviation 2.2 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 7 | -2.0 mmHg | Standard Deviation 2.8 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 21 | -2.0 mmHg | Standard Deviation 3.3 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 7 | -2.3 mmHg | Standard Deviation 3 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 21 | -1.2 mmHg | Standard Deviation 3.4 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 1000 PM Day 14 | -2.1 mmHg | Standard Deviation 2.3 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0800 AM Day 14 | -2.2 mmHg | Standard Deviation 2.7 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 1000 AM Day 21 | -1.5 mmHg | Standard Deviation 2.4 |
| VVN539 Ophthalmic Solution Vehicle | Mean Change in Intraocular Pressure From Baseline | 0400 PM Day 14 | -0.9 mmHg | Standard Deviation 3.5 |