Dry Eye Syndromes
Conditions
Brief summary
This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.
Detailed description
Participants will be randomized to a single application sequence, either sequence A (intranasal application followed by control application) or sequence B (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.
Interventions
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Moderate to severe dry eye disease * 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 * Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator * Corneal transplant in either or both eyes * A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit * Be 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 |
|---|---|---|
| Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) | Pre-application to Post-application on Day 0 | The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to no dryness and 100 corresponds to maximal dryness. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | Pre-application to Post-application on Day 0 | The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect. |
Countries
United States
Participant flow
Pre-assignment details
Intranasal and Extranasal data for this crossover study are combined because there is only access to combined arm data for this study. The study was acquired from another organization and limited results data are available.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes at Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure; followed by Intranasal Tear Neurostimulator device, intranasal or extranasal (control) application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥ 3 at 2 or more consecutive time points in at least one eye during CAE exposure. Randomization determined the order of intranasal or extranasal application. | 185 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Enrollment cap | 7 |
| Overall Study | Investigator Discretion | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Received Neither Application | 18 |
| Overall Study | Received One Application | 10 |
| Overall Study | Subject Choice | 4 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 138 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 171 |
| other Total, other adverse events | 0 / 171 |
| serious Total, serious adverse events | 0 / 171 |
Outcome results
Primary
Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS)
The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to no dryness and 100 corresponds to maximal dryness. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Time frame: Pre-application to Post-application on Day 0
Population: Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Application | Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) | -16.48 score on a scale | Standard Error 1.692 |
| Extranasal Application | Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) Using a Visual Analog Scale (VAS) | -3.12 score on a scale | Standard Error 1.692 |
p-value: <0.000195% CI: [-17.31, -9.4]ANOVA
Secondary
Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score
The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect.
Time frame: Pre-application to Post-application on Day 0
Population: Participants from the Full Analysis Set (FAS) Population, all randomized participants who initiated a study application, who received both intranasal and extranasal applications.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Application | Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | -0.93 score on a scale | Standard Error 0.08 |
| Extranasal Application | Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | -0.34 score on a scale | Standard Error 0.08 |
p-value: <0.000195% CI: [-0.8, -0.4]ANOVA