Dry Eye, Keratoconjunctivitis Sicca
Conditions
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
Detailed description
Protocol OPP-009 is a single center, open-label study to evaluate the safety of the nasal guide during administration of Tyrvaya (varenicline solution 0.03mg) Nasal Spray. Approximately 30 subjects at least 18 years of age will be enrolled at one clinical study site and will receive the nasal guide for use with the administration of Tyrvaya for 7 days.
Interventions
COMBINATION_PRODUCTNasal Guide
Use of Nasal Guide with administration of Tyrvaya (varenicline solution 0.03 mg) BID
Sponsors
Oyster Point Pharma, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Nasal guide will be used to aid in the administration of Tyrvaya® (varenicline solution 0.03 mg) Nasal Spray
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least 18 years of age 2. Have provided verbal and written informed consent 3. Willing to comply with all study related visits and procedures
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 7 days | Number of Participants with Adverse Events with use of the nasal guide |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nasal Guide 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 | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Nasal Guide |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 18.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 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 | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants With Adverse Events
Number of Participants with Adverse Events with use of the nasal guide
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tyrvaya Nasal Spray Administered With the Nasal Guide | Number of Participants With Adverse Events | 30 Participants |