Trial Outcomes & Findings for A Study Evaluating the Safety of the Nasal Pump (NCT NCT06329687)
NCT ID: NCT06329687
Last Updated: 2025-05-02
Results Overview
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
5 participants
Primary outcome timeframe
7 days
Results posted on
2025-05-02
Participant Flow
Participant milestones
| Measure |
Nasal Pump
Tyrvaya nasal pump with additional silicone lubricant
Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Evaluating the Safety of the Nasal Pump
Baseline characteristics by cohort
| Measure |
Nasal Pump
n=5 Participants
Tyrvaya nasal pump with additional silicone lubricant
Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant
|
|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 15.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 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
|
PRIMARY outcome
Timeframe: 7 daysNumber of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Outcome measures
| Measure |
Nasal Pump
n=5 Participants
Tyrvaya nasal pump with additional silicone lubricant
Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant
|
|---|---|
|
Number of Participants With Adverse Events
|
1 Participants
|
Adverse Events
Nasal Pump
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nasal Pump
n=5 participants at risk
Tyrvaya nasal pump with additional silicone lubricant
Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant
|
|---|---|
|
General disorders
Instillation Site Irritation
|
20.0%
1/5 • AE collection will start following the first administration of Tyrvaya® with additional silicone lubricant 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 additional silicone lubricant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place