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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Active Comparator | VVN539 Ophthalmic Solution 0.02% |
|
| VVN539 Ophthalmic Solution 0.04% | Active Comparator | VVN539 Ophthalmic Solution 0.04% |
|
| VVN539 Ophthalmic Solution Vehicle | Placebo Comparator | VVN539 Ophthalmic Solution Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVN539 Ophthalmic Solution 0.02% | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intraocular Pressure From Baseline | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiao-Yan Li, M.D. | VivaVision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexitas | Durham | North Carolina | 27701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | VVN539 Ophthalmic Solution 0.04% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Intraocular Pressure | mmHg | Full Analysis Set | Posted | Mean | Standard Deviation | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 |
|
21 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiao-Yan (Joanne) Li, M.D. | VivaVision Biotech, Inc. | (858) 692-9752 | joanne.li@vivavisionbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 7, 2022 | Dec 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2022 | Dec 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Double-masked, randomized, parallel
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Quadruple masking
| VVN539 Ophthalmic Solution 0.04% | Drug | 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 | Drug | 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 |
|
| Investigational Product Lot exchange |
|
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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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 |
|
|
| Secondary | Mean Change in Intraocular Pressure From Baseline | mmHg | Posted | Mean | Standard Deviation | mmHg | 8AM, 10AM, and 4PM at Day 7; Day 14 and Day 21 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 11 |
| 23 |
| EG001 | 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 | 0 | 22 | 0 | 22 | 10 | 22 |
| EG002 | 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 | 0 | 23 | 0 | 23 | 1 | 23 |
| Ocular hyperaemia | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 24.1 | Systematic Assessment |
|
All investigators will work collaboratively with the Sponsor on presentations and publications.
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| 0400 PM Day 7 |
|
| 0800 AM Day 14 |
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| 1000 PM Day 14 |
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| 0400 PM Day 14 |
|
| 0800 AM Day 21 |
|
| 1000 AM Day 21 |
|
| 0400 PM Day 21 |
|