Dry Eye Syndromes
Conditions
Brief summary
The objectives of this study are: * To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications * To compare the goblet cell count following application between the intranasal and extranasal applications * To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications
Detailed description
In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of: * Active intranasal device application * Active extranasal device application
Interventions
DEVICEOculeve Intranasal Lacrimal Neurostimulator
The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
Sponsors
Oculeve, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Bilateral dry eyes * Capable of providing written informed consent
Exclusion criteria
* Chronic or recurring epistaxis (nosebleeds) * Blood coagulation disorder * Uncontrolled or poorly controlled diabetes * Heart or pulmonary disease * Females who are pregnant, planning a pregnancy or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein Tear Clearance With Application | Day 1 |
Other
| Measure | Time frame |
|---|---|
| Level of Tear Proteins Pre and Post Administration | Day 1 |
| Level of Inflammatory Mediators Pre and Post Administration | Day 1 |
| Goblet Cell Count Following Application | Day 1 |
Countries
United States
Participant flow
Pre-assignment details
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Then Extranasal Application Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. | 0 |
| Extranasal Then Intranasal Application Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Fluorescein Tear Clearance With Application
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Goblet Cell Count Following Application
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Level of Inflammatory Mediators Pre and Post Administration
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Other Pre-specified
Level of Tear Proteins Pre and Post Administration
Time frame: Day 1
Population: During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.