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This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.
In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal then Extranasal Application | Experimental | Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
|
| Extranasal then Intranasal Application | Experimental | Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal Neurostimulator | Device | The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Tear Production by Jones Schirmer Test | Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Meniscus Height | Pre and Post Application on Days 15 and 29 | |
| Tear Meniscus Area | Pre and Post Application Days 15 and 29 | |
| Number of Secreting Meibomian Glands |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Torkildsen, MD | Andover Eye Associates | Principal Investigator |
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During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intranasal Then Extranasal Application | Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
| FG001 | Extranasal Then Intranasal Application | Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intranasal Then Extranasal Application | Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
| BG001 | Extranasal Then Intranasal Application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Acute Tear Production by Jones Schirmer Test | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Day 1 |
|
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During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Application | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. |
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During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
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| Day 1 |
| Tear Film Lipid Layer Thickness by Tearscope | Pre and Post Application on Days 15 and 29 |
| Lower Lid Margin Temperature | Pre and Post Application on Days 15 and 29 |
| Tear Film Temperature | Pre and Post Application on Days 15 and 29 |
| Number of Participants With Adverse Events | Up to 41 days |
Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
| BG002 | Total | Total of all reporting groups |
| years |
| Sex: Female, Male | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Other Pre-specified | Tear Meniscus Height | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Pre and Post Application on Days 15 and 29 |
|
|
| Other Pre-specified | Tear Meniscus Area | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Pre and Post Application Days 15 and 29 |
|
|
| Other Pre-specified | Number of Secreting Meibomian Glands | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Day 1 |
|
|
| Other Pre-specified | Tear Film Lipid Layer Thickness by Tearscope | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Pre and Post Application on Days 15 and 29 |
|
|
| Other Pre-specified | Lower Lid Margin Temperature | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Pre and Post Application on Days 15 and 29 |
|
|
| Other Pre-specified | Tear Film Temperature | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Pre and Post Application on Days 15 and 29 |
|
|
| Other Pre-specified | Number of Participants With Adverse Events | During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time. | Posted | Up to 41 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Extranasal Application | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. | 0 | 0 | 0 | 0 | 0 | 0 |
Authorship and manuscript composition will reflect cooperation among all parties involved in the study. Authorship will be established before writing the manuscript. The study sponsor and Ora will have the final decision regarding the manuscript and publication.
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |