A Phase 4 interventional study of Nasal Guide in Dry Eye and Keratoconjunctivitis Sicca, sponsored by Oyster Point Pharma, Inc.. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
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 nasal guide when utilized to aid in the administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray
Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 30 is below the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca 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..
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
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.
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Combination Product: Nasal Guide
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Number of Participants With Adverse Events
Number of Participants with Adverse Events with use of the nasal guide
Time frame: 7 days
| Milestone | Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Number of Participants with Adverse Events with use of the nasal guide
| Participants | Tyrvaya Nasal Spray Administered With the Nasal Guide |
|---|---|
| Number of Participants With Adverse Events | 30 |
Collected over AE collection will start following the first administration of Tyrvaya® utilizing the nasal guide 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 |
|---|---|---|---|
| Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide | 0/30 (0%) | 0/30 (0%) | 3/30 (10%) |
| Event | Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide |
|---|---|
| SneezingRespiratory, thoracic and mediastinal disorders | 3/30 |
| Age, Continuous(years) | Nasal Guide |
|---|---|
| Mean | 56.9 ± 18.99 |
| Sex: Female, Male(Participants) | Nasal Guide |
|---|---|
| Female | 20 |
| Male | 10 |
| Ethnicity (NIH/OMB)(Participants) | Nasal Guide |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 22 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Nasal Guide |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 6 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Nasal Guide |
|---|---|
| United States | 30 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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