Dry Eye, Dry Eye Syndromes
Conditions
Brief summary
This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.
Detailed description
Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.
Interventions
DEVICETrueTear
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Sponsors
Oculeve, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit * Normal lid/lash anatomy, blinking function and closure as determined by the Investigator * 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 risk of clinically significant increased bleeding * Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas * Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study * Corneal transplant in either or both eyes * Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head * A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study * Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eye Dryness Score | Day 45 | Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate no discomfort and 100 to indicate maximal discomfort. The assessment line length of the scale will be 100 mm. |
Countries
United States
Participant flow
Recruitment details
Of the 57 enrolled subjects, 54 subjects completed the study. All 57 subjects enrolled in the study were included in FAS and safety populations
Participants by arm
| Arm | Count |
|---|---|
| TrueTear The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. | 57 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
Baseline characteristics
| Characteristic | TrueTear |
|---|---|
| Age, Continuous | 60.3 Years STANDARD_DEVIATION 9.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 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 | 57 Participants |
| Sex/Gender, Customized Female | 43 Participants |
| Sex/Gender, Customized Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 57 |
| other Total, other adverse events | 0 / 57 |
| serious Total, serious adverse events | 0 / 57 |
Outcome results
Primary
Eye Dryness Score
Eye Dryness Score using a visual analog scale assessed in the Controlled Adverse Environment (CAE). The participant rates their current eye dryness (both eyes simultaneously) by scoring 0 to indicate no discomfort and 100 to indicate maximal discomfort. The assessment line length of the scale will be 100 mm.
Time frame: Day 45
Population: Of the 57 subjects that initiated the study, 48 subjects achieved the threshold and performed an application in the CAE at Day 45.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TrueTear | Eye Dryness Score | 48 Score on Scale | Standard Error 15.2 |
p-value: 0.0001ANCOVA