Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VVN001, 1% | Experimental | VVN001, 1% ophthalmic solution |
|
| VVN001, 5% | Experimental | VVN001, 5% ophthalmic solution |
|
| Vehicle | Placebo Comparator | VVN001 Ophthalmic Solution Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VVN001 Ophthalmic Solution 1% | Drug | VVN001 Ophthalmic Solution 1% |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inferior Corneal Fluorescein Staining | Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. | Day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Corneal Fluorescein Staining | Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20. | Day 84 |
| Regional Corneal Fluorescein Staining |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexitas | Durham | North Carolina | 27703 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36586669 | Result | Tauber J, Evans D, Segal B, Li XY, Shen W, Lu C, Novack GD; VVN001-CS201 Study Group. A phase 2a, double-masked, randomized, vehicle-controlled trial of VVN001 in subjects with dry eye disease. Ocul Surf. 2023 Apr;28:18-24. doi: 10.1016/j.jtos.2022.12.007. Epub 2022 Dec 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VVN001, 1% | VVN001, 1% ophthalmic solution VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1% |
| FG001 | VVN001, 5% | VVN001, 5% ophthalmic solution VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5% |
| FG002 | Vehicle | VVN001 Ophthalmic Solution Placebo Vehicle: VVN001 Ophthalmic Solution Vehicle |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VVN001, 1% | VVN001, 1% ophthalmic solution VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1% |
| BG001 | VVN001, 5% | VVN001, 5% ophthalmic solution VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5% |
| 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 | Inferior Corneal Fluorescein Staining | Mean change from baseline in Inferior corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. | Sample size reflects number of subjects evaluable at Day 84 | Posted | Mean | Standard Deviation | score on a scale | Day 84 |
|
84 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VVN001, 1% | VVN001, 1% ophthalmic solution VVN001 Ophthalmic Solution 1%: VVN001 Ophthalmic Solution 1% |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalzion | Eye disorders | MedDRA (23.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joanne Li, M.D. | VivaVision Biotech, Inc. | 86-02158598290 | joanne.li@vivavisionbio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2020 | Jan 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 13, 2022 | Jan 5, 2023 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Double-masked parallel
Not provided
Not provided
Double-masked
| VVN001 Ophthalmic Solution 5% |
| Drug |
VVN001 Ophthalmic Solution 5% |
|
| Vehicle | Drug | VVN001 Ophthalmic Solution Vehicle |
|
Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. |
| Day 84 |
| Eye Dryness | Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100.. | Day 84 |
| Lost to Follow-up |
|
| Subject travel |
|
| Physician Decision |
|
| BG002 | Vehicle | VVN001 Ophthalmic Solution Placebo Vehicle: VVN001 Ophthalmic Solution Vehicle |
| 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 |
|
| Inferior Corneal Fluorescein Staining | Scale: 0 (none) to 4 (severe) | Mean | Standard Deviation | units on a scale (0 none to 4 severe) |
|
| Eye Dryness Visual Analog Scale | Units on a scale: 0 (none) to 100 (severe) | Mean | Standard Deviation | units on a scale |
|
| Total Corneal Fluorescein Staining | Scale: 0 (none) to 20 (severe) | Mean | Standard Deviation | units on a scale |
|
| Regional corneal fluorescein staining | Scale: 0 (none) to 4 (severe) | Mean | Standard Deviation | units on a scale |
|
| OG002 | Vehicle | VVN001 Ophthalmic Solution Placebo Vehicle: VVN001 Ophthalmic Solution Vehicle |
|
|
| Secondary | Total Corneal Fluorescein Staining | Mean change from baseline in total corneal fluorescein staining Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -20 to +20. | Sample size reflects number of subjects evaluable at Day 84 | Posted | Mean | Standard Deviation | score on a scale | Day 84 |
|
|
|
| Secondary | Regional Corneal Fluorescein Staining | Mean change from baseline in temporal regional corneal fluorescein staining. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -4 to +4. | Sample size reflects number of subjects evaluable at Day 84 | Posted | Mean | Standard Deviation | score on a scale | Day 84 |
|
|
|
| Secondary | Eye Dryness | Mean Change in Eye Dryness VAS. Negative number indicates improvement. Depending upon individual subject's baseline, this measure can range from -100 to +100.. | Sample size reflects number of subjects evaluable at Day 84 | Posted | Mean | Standard Deviation | score on a scale | Day 84 |
|
|
|
| 0 |
| 57 |
| 0 |
| 56 |
| 3 |
| 56 |
| EG001 | VVN001, 5% | VVN001, 5% ophthalmic solution VVN001 Ophthalmic Solution 5%: VVN001 Ophthalmic Solution 5% | 0 | 56 | 0 | 57 | 6 | 57 |
| EG002 | Vehicle | VVN001 Ophthalmic Solution Placebo Vehicle: VVN001 Ophthalmic Solution Vehicle | 0 | 56 | 0 | 56 | 2 | 56 |
| Instillation site pain | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
| Dysguesia | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
|
Not provided
Not provided