Dry Eye Syndromes
Conditions
Keywords
Dry Eye Disease
Brief summary
The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.
Interventions
DEVICEIntranasal Tear Neurostimulator (ITN) [TrueTear®]
The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol * Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study * The participant should be literate, able to speak English, and able to complete questionnaires independently
Exclusion criteria
* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding * Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas * Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device * Corneal transplant in either or both eyes * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study * Women who are pregnant, planning a pregnancy, or nursing throughout the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Ratio of Degranulated Goblet Cells. | Screening (Day -60 to Day -30) to Application Visit (Day 0) | Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ITN [TrueTear®] - Intranasal Application Intranasal application of the ITN. Single application at application visit. | 9 |
| ITN [TrueTear®] - Extranasal Application Extranasal application of the ITN. Single application at application visit. | 5 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued due to Study Termination | 1 | 0 |
Baseline characteristics
| Characteristic | ITN [TrueTear®] - Extranasal Application | Total | ITN [TrueTear®] - Intranasal Application |
|---|---|---|---|
| Age, Continuous | 46.8 Years STANDARD_DEVIATION 10.4 | 52.2 Years STANDARD_DEVIATION 14 | 55.2 Years STANDARD_DEVIATION 15.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 10 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 5 |
| other Total, other adverse events | 0 / 9 | 0 / 5 |
| serious Total, serious adverse events | 0 / 9 | 0 / 5 |
Outcome results
Primary
Difference in Ratio of Degranulated Goblet Cells.
Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit
Time frame: Screening (Day -60 to Day -30) to Application Visit (Day 0)
Population: Of the 14 Randomized participants, 13 received a single application of the Intranasal Tear Neurostimulator (ITN)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITN [TrueTear®] - Intranasal Application | Difference in Ratio of Degranulated Goblet Cells. | 0.007 Ratio | Standard Deviation 0.171 |
| ITN [TrueTear®] - Extranasal Application | Difference in Ratio of Degranulated Goblet Cells. | 0.124 Ratio | Standard Deviation 0.069 |