Dry Eye Syndrome, Keratoconjunctivitis Sicca
Conditions
Brief summary
The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
Detailed description
This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.
Interventions
DEVICEOculeve Intranasal
Oculeve device, intranasal (test) application for approximately 3 minutes.
DEVICESham
Sham device (control), intranasal application for approximately 3 minutes.
DEVICEOculeve Extranasal
Oculeve device, extranasal (control) application for approximately 3 minutes.
Sponsors
Oculeve, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Intervention model description
Three way cross-over study with 6 sequences.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with aqueous tear deficiency * Literate, able to speak English or Spanish, and able to complete questionnaires independently * Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol
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 nasal cautery or significant trauma * Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device * Diagnosis of epilepsy * Corneal transplant in either or both eyes * Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit * A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Stimulated Tear Production | Day 0 post-application | Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye. |
| Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Day 0 | An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular. |
Other
| Measure | Time frame |
|---|---|
| Pulse Rate | 1-Day |
| Corrected Distance Visual Acuity | 1-Day |
| Blood Pressure | 1-Day |
| Oxygen Saturation | 1-Day |
| Slit Lamp Biomicroscopy | 1-Day |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0. | 48 |
| All Study Participants All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0. | 48 |
| Total | 96 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 13.17 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 48 | 0 / 48 |
| other Total, other adverse events | 4 / 48 | 0 / 48 | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 | 0 / 48 | 0 / 48 |
Outcome results
Primary
Acute Stimulated Tear Production
Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye.
Time frame: Day 0 post-application
Population: The FAS population included all randomized participants who were exposed to study application.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oculeve Intranasal | Acute Stimulated Tear Production | 25.3 mm | Standard Deviation 10.7 |
| Sham | Acute Stimulated Tear Production | 9.2 mm | Standard Deviation 7.34 |
| Oculeve Extranasal | Acute Stimulated Tear Production | 9.5 mm | Standard Deviation 8.15 |
Primary
Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE)
An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular.
Time frame: Day 0
Population: Safety population included all randomized participants who were exposed to study application.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Oculeve Intranasal | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Ocular) | 0 percentage of participants |
| Oculeve Intranasal | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Non-ocular) | 4.2 percentage of participants |
| Sham | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Ocular) | 0 percentage of participants |
| Sham | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Non-ocular) | 0 percentage of participants |
| Oculeve Extranasal | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Ocular) | 0 percentage of participants |
| Oculeve Extranasal | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | Device-related AEs (Non-ocular) | 0 percentage of participants |
Other Pre-specified
Blood Pressure
Time frame: 1-Day
Other Pre-specified
Corrected Distance Visual Acuity
Time frame: 1-Day
Other Pre-specified
Oxygen Saturation
Time frame: 1-Day
Other Pre-specified
Pulse Rate
Time frame: 1-Day
Other Pre-specified
Slit Lamp Biomicroscopy
Time frame: 1-Day