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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueTear Intranasal Tear Neurostimulator | Device | This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer Testing | Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production. | Immediately following the procedure (ie immediately following use of the device) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Changes in Visual Acuity | Clinically significant change in Best corrected visual acuity (BCVA)- this measurement was taken to determine if a significant change in BCVA was noted for participants. If a clinically significant change was noted (greater or equal to 2 lines of vision) then a subject would be listed in the data table below. | Immediately following the procedure (ie immediately following use of the device) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giacomina Massaro-Giordano, MD | Scheie Eye Insitute, University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scheie Eye Institute, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | The participants recruited for this study were those who were 22 years or older, had a clinical diagnosis of Sjogren's Syndrome (SS), and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips). They also had to have an OSDI score ≥13. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Same as assignment in Participant Flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | The participants recruited for this study were those who had a clinical diagnosis of Sjogren's Syndrome (SS) and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips). |
| 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 | Schirmer Testing | Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production. | Posted | Mean | Standard Deviation | mm. | Immediately following the procedure (ie immediately following use of the device) |
|
Adverse events were collected throughout the duration of the study (from the time the patient was enrolled in the study until they completed visit 2). We also provided patients with our contact information, in case they experienced any adverse events in the days following visit 2.
The adverse event data was collected immediately following the event. The subject was also called a week later to ensure that the issue had resolved.
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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 | Study Group | The participants recruited for this study were those who had a clinical diagnosis of Sjogren's Syndrome (SS) and produced 10 mm. or less of tears over the course of 5 minutes (measured using Schirmer strips). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small conjunctival hemorrhage | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Penn Medicine | 215-662-9393 | jonathan.lilley@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2019 | Sep 10, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2018 | Apr 21, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
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| Clinically Significant Changes in Slit Lamp Exam | Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below. | Immediately following the procedure (ie immediately following use of the device) |
| Number of Adverse Events | Pain, headache, nosebleed, etc felt to be associated with use of the device | Immediately following the procedure (ie immediately following use of the device) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Year of Sjogren's diagnosis | Count of Participants | Participants |
|
| OSDI Score | [low of 0, high of 100] Higher score means more affected by dry eye symptoms, lower score means less affected by dry eye symptoms- OSDI score defined the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | Mean | Standard Deviation | units on a scale |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Clinically Significant Changes in Visual Acuity | Clinically significant change in Best corrected visual acuity (BCVA)- this measurement was taken to determine if a significant change in BCVA was noted for participants. If a clinically significant change was noted (greater or equal to 2 lines of vision) then a subject would be listed in the data table below. | Participants' eyes were examined pre and post active application to confirm that the device did not cause any changes to the participant's vision. A serious change in vision would have been reported as an adverse event | Posted | Count of Participants | Participants | Immediately following the procedure (ie immediately following use of the device) |
|
|
|
| Secondary | Clinically Significant Changes in Slit Lamp Exam | Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below. | Eyes were examined pre and post active application to confirm that the device did not cause any changes to the physical structure or appearance of the eyes | Posted | Count of Participants | Participants | Immediately following the procedure (ie immediately following use of the device) |
|
|
|
| Secondary | Number of Adverse Events | Pain, headache, nosebleed, etc felt to be associated with use of the device | All participants who used the device were observed for any adverse events | Posted | Number | occurance of adverse event | Immediately following the procedure (ie immediately following use of the device) |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 1 |
| 55 |
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |