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The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.
This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1-Intranasal: Extranasal: Sham | Experimental | Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
|
| Sequence 2-Intranasal: Sham: Extranasal | Experimental | Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
|
| Sequence 3-Extranasal: Intranasal: Sham | Experimental | Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
|
| Sequence 4-Extranasal: Sham: Intranasal | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oculeve Intranasal | Device | Oculeve device, intranasal (test) application for approximately 3 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Stimulated Tear Production | Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye. | Day 0 post-application |
| Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular. | Day 0 |
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| Measure | Description | Time Frame |
|---|---|---|
| Corrected Distance Visual Acuity | 1-Day | |
| Slit Lamp Biomicroscopy | 1-Day | |
| Pulse Rate |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Senchyna | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Care Group | Waterbury | Connecticut | 06708 | United States | ||
| Virginia Eye Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30472141 | Derived | Sheppard JD, Torkildsen GL, Geffin JA, Dao J, Evans DG, Ousler GW, Wilson J, Baba SN, Senchyna M, Holland EJ. Characterization of tear production in subjects with dry eye disease during intranasal tear neurostimulation: Results from two pivotal clinical trials. Ocul Surf. 2019 Jan;17(1):142-150. doi: 10.1016/j.jtos.2018.11.009. Epub 2018 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 - Intranasal : Extranasal : Sham | Oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device, intranasal (control) application, for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Three way cross-over study with 6 sequences.
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Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application.
|
| Sequence 5-Sham: Intranasal: Extranasal | Experimental | Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
|
| Sequence 6-Sham: Extranasal: Intranasal | Experimental | Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
|
| Sham | Device | Sham device (control), intranasal application for approximately 3 minutes. |
|
| Oculeve Extranasal | Device | Oculeve device, extranasal (control) application for approximately 3 minutes. |
|
| 1-Day |
| Oxygen Saturation | 1-Day |
| Blood Pressure | 1-Day |
| Norfolk |
| Virginia |
| 23502 |
| United States |
| FG001 | Sequence 2 - Intranasal : Sham : Extranasal | Oculeve device, intranasal (test) application for approximately 3 minutes followed by sham device, intranasal (control) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| FG002 | Sequence 3 - Extranasal: Intranasal: Sham | Oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes, followed by sham device (control), intranasal application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| FG003 | Sequence 4 - Extranasal : Sham : Intranasal | Oculeve device, extranasal (control) application for approximately 3 minutes followed by sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| FG004 | Sequence 5 - Sham : Intranasal : Extranasal | Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| FG005 | Sequence 6 - Sham : Extranasal : Intranasal | Sham device (control), intranasal application for approximately 3 minutes followed by oculeve device, extranasal (control) application for approximately 3 minutes followed by oculeve device, intranasal (test) application for approximately 3 minutes followed by on Day 0. There was rest period of 60 minutes before proceeding to the next application. |
| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who were exposed to study application.
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants who received oculeve device, intranasal (test) application, extranasal (control) and sham device, intranasal (control) application, for approximately 3 minutes on Day 0. |
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| 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 Stimulated Tear Production | Stimulated acute tear production in the study eye at Day 0 as measured by the difference between the Schirmer test score during stimulation and the test score before stimulation (basal). The Schirmer strip is placed just under the eyelid and wicks up the tears. It measures tear production on a linear scale of 0-35 mm. The study eye was defined as the eye with the greatest increase in tear production with stimulation by the cotton swab at Visit 1/Screening or, if there was no difference in stimulated tear production, the eye with the lower basal Schirmer score at Visit 2/Day 0 was selected. If there was no difference for either measure, the right eye was used as the study eye. | The FAS population included all randomized participants who were exposed to study application. | Posted | Mean | Standard Deviation | mm | Day 0 post-application | eyes | eyes |
|
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| |||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experienced One or More Device-related Adverse Event (AE) | An AE is defined as any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs in participants, users or other persons it does not necessarily have to have a causal relationship with the investigational medical device. Device-related AEs were presented as ocular and non-ocular. | Safety population included all randomized participants who were exposed to study application. | Posted | Number | percentage of participants | Day 0 | eyes | eyes |
|
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| Other Pre-specified | Corrected Distance Visual Acuity | Not Posted | 1-Day | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Slit Lamp Biomicroscopy | Not Posted | 1-Day | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Pulse Rate | Not Posted | 1-Day | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Oxygen Saturation | Not Posted | 1-Day | Participants | ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Blood Pressure | Not Posted | 1-Day | Participants |
Day 0
Safety population included all randomized participants who were exposed to study applications.
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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 | Oculeve Intranasal | Oculeve device, intranasal (test) application for approximately 3 minutes on Day 0 | 0 | 48 | 0 | 48 | 4 | 48 |
| EG001 | Sham | Sham device (control), intranasal application for approximately 3 minutes on Day 0 | 0 | 48 | 0 | 48 | 0 | 48 |
| EG002 | Oculeve Extranasal | Oculeve device, extranasal (control) application for approximately 3 minutes on Day 0 | 0 | 48 | 0 | 48 | 0 | 48 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Slight transient lightheadedness | General disorders | Systematic Assessment |
| ||
| Intermittent nose itching | General disorders | Systematic Assessment |
| ||
| Exacerbation of hypertension | General disorders | Systematic Assessment |
| ||
| Corneal abrasion | Eye disorders | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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| Participants |
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| eyes |
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