Tear Production by Nasal Neurostimulation Compared to Active Control
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Device: Intranasal Neurostimulator
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
|
Experimental: Extranasal then Intranasal Application 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. |
Device: Intranasal Neurostimulator
The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
|
Outcome Measures
Primary Outcome Measures
- Acute Tear Production by Jones Schirmer Test [Day 1]
Other Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Mild to severe dry eye disease
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Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
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Literate, able to speak English or Spanish, and able to complete questionnaires independently
Exclusion Criteria:
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Previously used the Intranasal Neurostimulator at any time
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Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
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Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
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Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
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Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
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Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
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Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oculeve, Inc.
Investigators
- Principal Investigator: Gail Torkildsen, MD, Andover Eye Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OCUN-016B
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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. |
Arm/Group Title | Intranasal Then Extranasal Application | Extranasal Then Intranasal Application |
---|---|---|
Arm/Group Description | 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. | Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. |
Period Title: Overall Study | ||
STARTED | 0 | 0 |
COMPLETED | 0 | 0 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Intranasal Then Extranasal Application | Extranasal Then Intranasal Application | Total |
---|---|---|---|
Arm/Group Description | 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. | Intranasal Neurostimulator applied extranasally (control) on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29. | Total of all reporting groups |
Overall Participants | 0 | 0 | 0 |
Age (years) [] | |||
Sex: Female, Male (participants) [] | |||
Female | |||
Male |
Outcome Measures
Title | Acute Tear Production by Jones Schirmer Test |
---|---|
Description | |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Tear Meniscus Height |
---|---|
Description | |
Time Frame | Pre and Post Application on Days 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Tear Meniscus Area |
---|---|
Description | |
Time Frame | Pre and Post Application Days 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Number of Secreting Meibomian Glands |
---|---|
Description | |
Time Frame | Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Tear Film Lipid Layer Thickness by Tearscope |
---|---|
Description | |
Time Frame | Pre and Post Application on Days 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Lower Lid Margin Temperature |
---|---|
Description | |
Time Frame | Pre and Post Application on Days 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Tear Film Temperature |
---|---|
Description | |
Time Frame | Pre and Post Application on Days 15 and 29 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Title | Number of Participants With Adverse Events |
---|---|
Description | |
Time Frame | Up to 41 days |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Intranasal Application | Extranasal Application |
---|---|---|
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. |
Measure Participants | 0 | 0 |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||
Arm/Group Title | Intranasal Application | Extranasal Application | ||
Arm/Group Description | Intranasal Neurostimulator applied intranasally (active) on Day 1 and Day 15 or 29. | Intranasal Neurostimulator applied extranasally (control) on Day 1 and Day 15 or 29. | ||
All Cause Mortality |
||||
Intranasal Application | Extranasal Application | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
Intranasal Application | Extranasal Application | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
Intranasal Application | Extranasal Application | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/0 (NaN) | 0/0 (NaN) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Therapeutic Area, Head |
---|---|
Organization | Allergan |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- OCUN-016B