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The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSJ-110 Solution | Experimental |
| |
| Placebo Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSJ-110 | Drug | ophthalmic solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Itching as Measured by Self-reported Numerical Scales | Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching) | 16 hours, 8 hours, and 15 minutes post-treatment |
| Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | Change from baseline in conjunctival redness evaluated by the investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more redness) | 16 hours, 8 hours, and 15 minutes post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | Conjunctival redness responder rates evaluated by the investigator at 7(±1), 15(±1), and 20(±1) minutes post allergen challenge. A responder is defined as meeting 1, 1.5, or 2 points reduction from baseline, or complete response in all three time points or at least two out of the three timepoints. | 16 hours, 8 hours, and 15 minutes post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VSJ-110 | VSJ-110 Ophthalmic Solution |
| FG001 | Placebo | Placebo Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VSJ-110 | VSJ-110 Ophthalmic Solution |
| BG001 | Placebo | Placebo Ophthalmic Solution |
| 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 | Ocular Itching as Measured by Self-reported Numerical Scales | Change from baseline in ocular itching evaluated by the subject at 3(±1), 5(±1), and 7(±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more itching) | Efficacy analysis performed on ITT and PP populations | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 16 hours, 8 hours, and 15 minutes post-treatment |
|
AE data was collected during the 4 week treatment period plus a 7 day follow up period.
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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 | VSJ-110 Solution | VSJ-110: ophthalmic solution | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | 202-734-3400 | clinicaltrials@vandapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2020 | Mar 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Drug |
ophthalmic solution |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Conjunctival Redness as Measured by Investigator Assessed Numerical Scales | Change from baseline in conjunctival redness evaluated by the investigator at 7 (±1), 15 (±1), and 20 (±1) minutes post allergen challenge (0-4 scale, with a higher number indicating more redness) | Efficacy analysis performed on ITT and PP populations | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 16 hours, 8 hours, and 15 minutes post-treatment |
|
|
|
| Secondary | Conjunctival Redness Responder Rates as Evaluated by the Investigator Using Numerical Scales | Conjunctival redness responder rates evaluated by the investigator at 7(±1), 15(±1), and 20(±1) minutes post allergen challenge. A responder is defined as meeting 1, 1.5, or 2 points reduction from baseline, or complete response in all three time points or at least two out of the three timepoints. | Posted | Count of Participants | Participants | 16 hours, 8 hours, and 15 minutes post-treatment |
|
|
|
| 24 |
| 0 |
| 24 |
| 2 |
| 24 |
| EG001 | Placebo Solution | Placebo: ophthalmic solution | 0 | 23 | 1 | 23 | 0 | 23 |
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| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |
| 16 hours (15(±1) minutes post-challenge) |
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| 16 hours (20(±1) minutes post-challenge) |
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| 8 hours (7(±1) minutes post-challenge) |
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| 8 hours (15(±1) minutes post-challenge) |
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| 8 hours (20(±1) minutes post-challenge) |
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| 15 minutes (7(±1) minutes post-challenge) |
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| 15 minutes (15(±1) minutes post-challenge) |
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| 15 minutes (20(±1) minutes post-challenge) |
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| 15 minutes (rates across all three time points) |
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| 16 hours (rates across two out of the three timepoints) |
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| 8 hours (rates across two out of the three timepoints) |
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| 15 minutes (rates across two out of the three timepoints) |
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