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The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.
This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active - Device | Experimental | The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oculeve Intranasal Neurostimulator | Device | Neurostimulation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tear Meniscus Height Captured by Optical Coherence Tomography | Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Friedman, MD | Mid-Peninsula Ophthalmology Medical Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sall Research Medical Center | Artesia | California | 90701 | United States | ||
| Aesthetic Eyecare Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active - Device | The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active - Device | The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Tear Meniscus Height Captured by Optical Coherence Tomography | Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography. | Safety population included all subjects who received device intervention. | Posted | Mean | Standard Deviation | µm | Day 1 |
|
|
Day 0 to Day 22
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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 | Active - Device | The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 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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| Newport Beach |
| California |
| 92663 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 55 |
| 0 |
| 55 |
The data provided by this clinical trial, and all related information and any materials containing such data and information, are the exclusive property of Oculeve and are confidential to Oculeve. 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.
| D003229 |
| Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |