Trial Outcomes & Findings for Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya (NCT NCT05918406)

Last Updated: 2025-05-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

7 days

Results posted on

2025-05-06

Participant milestones
Measure	Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide Subjects will administer Tyrvaya BID with nasal guide for 7 days
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Phase 4 Study Evaluating the Safety of the Nasal Guide With Tyrvaya

Baseline characteristics by cohort
Measure	Nasal Guide n=30 Participants Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID Nasal Guide: Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Age, Continuous	56.9 years STANDARD_DEVIATION 18.99 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

Timeframe: 7 days

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

Outcome measures
Measure	Tyrvaya Nasal Spray Administered With the Nasal Guide n=30 Participants Subjects will administer Tyrvaya (varenicline solution 0.3mg) BID with nasal guide for 7 days
Number of Participants With Adverse Events	30 Participants

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide n=30 participants at risk Subjects will administer Tyrvaya BID with nasal guide for 7 days
Respiratory, thoracic and mediastinal disorders Sneezing	10.0% 3/30 • 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. The safety population will include all enrolled subjects who received at least one Tyrvaya® administered with the nasal guide.

Oyster Point Pharma Inc

Phone: 312-259-2477