Dry EyePhase 4NCT06329687
A Study Evaluating the Safety of the Nasal Pump
A Phase 4 study testing Tyrvaya Nasal Pump in people with Dry Eye and Kerato Conjunctivitis Sicca, run by Oyster Point Pharma, Inc. at 1 site in United States.
Trial summary
The objective of this study is to determine the safety of the Tyrvaya nasal pump. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Kerato Conjunctivitis Sicca
- What is being tested?
- Tyrvaya Nasal Pump
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2024to 28 Feb 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Have provided verbal and written informed consent
- Willing to comply with all study related visits and procedures
Who cannot join
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Trial locations and contacts
1 site in 1 country.
United States1 site
United States, California
Newport Beach, California, 92663
About this study
Official title: A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump
The objective of this study is to determine the safety of the Tyrvaya nasal pump.
Read the detailed description
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.
- Conditions
- Dry Eye, Kerato Conjunctivitis Sicca
- Being tested
- Tyrvaya Nasal Pump
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyrvaya Nasal PumpDrug
Tyrvaya Nasal Pump with Silicone Lubricant
| Study group | Role | What they receive |
|---|---|---|
| Nasal Pump | Experimental | Tyrvaya nasal pump with additional silicone lubricant Receives: Drug: Tyrvaya Nasal Pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start21 Feb 2024
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Why it stopped: Internal strategy change. Not related to safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oyster Point Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329687
- Sponsor's protocol ID
- OPP-010
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 2 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4, Single-Center, Open-Label Study Evaluating the Safety of the Tyrvaya Nasal Pump
- ClinicalTrials.gov ID
- NCT06329687
- Acronym / sponsor ID
- OPP-010
- Conditions
- Dry Eye, Kerato Conjunctivitis Sicca
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal strategy change. Not related to safety concerns.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oyster Point Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Posted 2 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the safety of the Tyrvaya nasal pump.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasal Pump | Experimental | Drug: Tyrvaya Nasal PumpTyrvaya nasal pump with additional silicone lubricant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age
- Have provided verbal and written informed consent
- Willing to comply with all study related visits and procedures
Key exclusion criteria (1 listed)
- Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyrvaya Nasal PumpTyrvaya Nasal Pump with Silicone Lubricant | Drug | Nasal Pump |
Primary outcome
Number of Participants With Adverse Events
Time frame: 7 days
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Dry Eye
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tyrvaya Nasal Pump in people with Dry Eye and Kerato Conjunctivitis Sicca, run by Oyster Point Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.