NCT05918406

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

June 14, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

May 6, 2025

Completed
Last Updated

May 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

June 15, 2023

Results QC Date

March 24, 2025

Last Update Submit

May 1, 2025

Conditions

Dry EyeKeratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    Number of Participants with Adverse Events with use of the nasal guide

    7 days

Study Arms (1)

Nasal Guide

EXPERIMENTAL

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Combination Product: Nasal Guide

Interventions

Nasal GuideCOMBINATION_PRODUCT

Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID

Nasal Guide

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:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

United States, New Jersey

Edison, New Jersey, 08820, United States

Location

United States, New Jersey

Woodland Park, New Jersey, 07424, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesKeratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesKeratoconjunctivitisConjunctivitisConjunctival DiseasesKeratitisCorneal Diseases

Results Point of Contact

Title
Marian Macsai, MD
Organization
Oyster Point Pharma Inc
marian.macsai@viatris.com
312-259-2477

Study Officials

  • Marian Macsai, MD

    Oyster Point Pharma

    STUDY DIRECTOR

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
Model Details: Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

June 14, 2023

Primary Completion

August 18, 2023

Study Completion

August 18, 2023

Last Updated

May 6, 2025

Results First Posted

May 6, 2025

Record last verified: 2025-03

Locations

US(2)