NCT06329687

Brief Summary

The objective of this study is to determine the safety of the Tyrvaya nasal pump.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

March 1, 2024

Enrollment Period

7 days

First QC Date

March 19, 2024

Results QC Date

March 24, 2025

Last Update Submit

April 16, 2025

Conditions

Dry EyeKerato Conjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant

    7 days

Study Arms (1)

Nasal Pump

EXPERIMENTAL

Tyrvaya nasal pump with additional silicone lubricant

Drug: Tyrvaya Nasal Pump

Interventions

Tyrvaya Nasal PumpDRUG

Tyrvaya Nasal Pump with Silicone Lubricant

Nasal Pump

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years of age
  • Have provided verbal and written informed consent
  • Willing to comply with all study related visits and procedures

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States, California

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Results Point of Contact

Title
Marian Macsai, MD
Organization
Oyster Point Pharma Inc
marian.macsai@viatris.com
3122592477

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

February 21, 2024

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

May 2, 2025

Results First Posted

May 2, 2025

Record last verified: 2024-03

Locations

US(1)