Dry Eye, Kerato Conjunctivitis Sicca
Conditions
Brief summary
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.
Interventions
DRUGTyrvaya Nasal Pump
Tyrvaya Nasal Pump with Silicone Lubricant
Sponsors
Oyster Point Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be at least 18 years of age * Have provided verbal and written informed consent * Willing to comply with all study related visits and procedures
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 7 days | Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Pump Tyrvaya nasal pump with additional silicone lubricant
Tyrvaya Nasal Pump: Tyrvaya Nasal Pump with Silicone Lubricant | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Nasal Pump |
|---|---|
| Age, Continuous | 68.8 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Participants With Adverse Events
Number of Participants with Adverse Events with the nasal pump with additional silicone lubricant
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nasal Pump | Number of Participants With Adverse Events | 1 Participants |