An interventional study of Intranasal Neurostimulator in Dry Eye, Dry Eye Syndromes and Keratoconjunctivitis Sicca, sponsored by Oculeve, Inc.. Completed. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Oculeve, Inc. · Not applicable, Interventional, and Other
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 27 is below the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Oculeve, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Compared within Keratoconjunctivitis Sicca, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dry Eye Syndromes. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Acute Tear Production by Jones Schirmer Test
Time frame: Day 1
Tear Meniscus Height
Time frame: Pre and Post Application on Days 15 and 29
Tear Meniscus Area
Time frame: Pre and Post Application Days 15 and 29
Number of Secreting Meibomian Glands
Time frame: Day 1
Tear Film Lipid Layer Thickness by Tearscope
Time frame: Pre and Post Application on Days 15 and 29
Lower Lid Margin Temperature
Time frame: Pre and Post Application on Days 15 and 29
Tear Film Temperature
Time frame: Pre and Post Application on Days 15 and 29
Number of Participants With Adverse Events
Time frame: Up to 41 days
| Milestone | Intranasal Then Extranasal Application | Extranasal Then Intranasal Application |
|---|---|---|
| Started | 0 | 0 |
| Completed | 0 | 0 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Application | — | — | — |
| Extranasal Application | — | — | — |
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.
| Age, Continuous(years) | Intranasal Then Extranasal Application | Extranasal Then Intranasal Application | Total |
|---|
| Sex: Female, Male(participants) | Intranasal Then Extranasal Application | Extranasal Then Intranasal Application | Total |
|---|---|---|---|
| Female | — | — | — |
| Male | — | — | — |
No study locations are listed for this record.
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Oculeve, Inc.