Dry Eye Syndromes
Conditions
Keywords
dry eye syndrome, keratoconjunctivitis, ophthalmic, eye disease, corneal disease, keratitis
Brief summary
The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.
Interventions
Neurostimulation applied intranasally and extranasally.
Sponsors
ORA, Inc.
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
* Bilateral dry eyes * Capable of providing written informed consent
Exclusion criteria
* Chronic or recurring epistaxis (nosebleeds) * Uncontrolled systemic disease * Blood coagulation disorder * Females who are pregnant, nursing or planning a pregnancy
Design outcomes
Primary
| 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 first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) 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. |
Countries
United States
Participant flow
Pre-assignment details
21 participants were enrolled. 1 participant had an adverse event (pre-existing condition), did not receive treatment and was withdrawn prior to controlled adverse environment (CAE) exposure.
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 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
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 first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; \>10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement.
Time frame: Pre-application to Post-application on Day 0
Population: Per-Protocol (PP) Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Application | Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | -1.1 score on a scale | Standard Deviation 1 |
| Extranasal Application | Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | -0.4 score on a scale | Standard Deviation 0.8 |
p-value: 0.00895% CI: [-1, -0.19]Paired t-test
Secondary
Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) 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.
Time frame: Pre-application to Post-application on Day 0
Population: PP Population was defined as all participants that were able to return to the threshold level following both treatments and did not have any significant protocol violations that might be expected to alter the outcome of their study results
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Application | Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS) | -18.7 score on a scale | Standard Deviation 26.4 |
| Extranasal Application | Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS) | -7.1 score on a scale | Standard Deviation 15.9 |
p-value: 0.00495% CI: [-19, -3.4]Paired t-test