A Phase 4 interventional study of Tyrvaya Nasal Pump in Dry Eye and Kerato Conjunctivitis Sicca, sponsored by Oyster Point Pharma, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-02.
Sponsored by Oyster Point Pharma, Inc. (part of Viatris Inc.) · Phase 4, Interventional, and Treatment
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 5 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Oyster Point Pharma, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
First submitted after Oyster Point Pharma, Inc. became part of Viatris Inc..
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tyrvaya nasal pump with additional silicone lubricant
Drug: Tyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant
Number of Participants With Adverse Events
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Time frame: 7 days
| Milestone | Nasal Pump |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
| Participants | Nasal Pump |
|---|---|
| Number of Participants With Adverse Events | 1 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nasal Pump | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Event | Nasal Pump |
|---|---|
| Instillation Site IrritationGeneral disorders | 1/5 |
| Age, Continuous(years) | Nasal Pump |
|---|---|
| Mean | 68.8 ± 15.0 |
| Sex: Female, Male(Participants) | Nasal Pump |
|---|---|
| Female | 4 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Nasal Pump |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nasal Pump |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 4 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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