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Internal strategy change. Not related to safety concerns.
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The objective of this study is to determine the safety of the Tyrvaya nasal pump.
The study is testing the hypothesis that the use of the Tyrvaya nasal pump with silicone lubricant does not introduce any additional safety concerns as compared to the safety of the Tyrvaya nasal pump without the additional silicone lubricant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Pump | Experimental | Tyrvaya nasal pump with additional silicone lubricant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tyrvaya Nasal Pump | Drug | Tyrvaya Nasal Pump with Silicone Lubricant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, California | Newport Beach | California | 92663 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nasal Pump | Tyrvaya nasal pump with additional silicone lubricant Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nasal Pump | Tyrvaya nasal pump with additional silicone lubricant Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Adverse Events | Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant | Posted | Count of Participants | Participants | 7 days |
|
|
AE collection will start following the first administration of Tyrvaya® with additional silicone lubricant until the last follow up visit of the study at 7 days.
The safety population will include all enrolled subjects who received at least one Tyrvaya ®administered with the additional silicone lubricant.
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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 | Nasal Pump | Tyrvaya nasal pump with additional silicone lubricant Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation Site Irritation | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Macsai, MD | Oyster Point Pharma Inc | 3122592477 | marian.macsai@viatris.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 21, 2023 | Apr 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
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