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The objectives of this study are:
In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal then Extranasal Application | Experimental | Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
|
| Extranasal then Intranasal Application | Active Comparator | Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oculeve Intranasal Lacrimal Neurostimulator | Device | The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system. |
| Measure | Description | Time Frame |
|---|---|---|
| Fluorescein Tear Clearance With Application | Day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Level of Tear Proteins Pre and Post Administration | Day 1 | |
| Level of Inflammatory Mediators Pre and Post Administration | Day 1 | |
| Goblet Cell Count Following Application |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lewis, MD | Grutzmacher, Lewis & Sierra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grutzmacher, Lewis & Sierra | Sacramento | California | 95815 | United States | ||
| Baylor College of Medicine, Department of Ophthalmology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28302532 | Derived | Gumus K, Schuetzle KL, Pflugfelder SC. Randomized Controlled Crossover Trial Comparing the Impact of Sham or Intranasal Tear Neurostimulation on Conjunctival Goblet Cell Degranulation. Am J Ophthalmol. 2017 May;177:159-168. doi: 10.1016/j.ajo.2017.03.002. Epub 2017 Mar 14. |
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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 application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
| FG001 | Extranasal Then Intranasal Application | Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
| 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 application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
| 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 | Fluorescein Tear Clearance With 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. | 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 application of the Oculeve Intranasal Lacrimal Neurostimulator. |
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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 |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Day 1 |
| Houston |
| Texas |
| 77030 |
| United States |
Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. |
| BG002 | Total | Total of all reporting groups |
| years |
| Sex: Female, Male | participants |
|
| Units | Counts |
|---|
| Participants |
|
| Other Pre-specified | Level of Tear Proteins Pre and Post Administration | 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 | Level of Inflammatory Mediators Pre and Post Administration | 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 | Goblet Cell Count Following 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. | Posted | Day 1 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Extranasal Application | Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. | 0 | 0 | 0 | 0 | 0 | 0 |
The investigator or other study-related personnel may not disclose to anyone or use any data, information, or materials related to this clinical trial without the express written consent of Oculeve.