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Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label Treatment | Other | Single metered spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MydCombi | Combination Product | A single metered spray administered with the MydCombi dispenser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pupil Diameter | Mean change in pupil diameter at 30 minutes from the time of drug dose versus baseline, as measured by digital pupillometry in highly photopic conditions | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 6.0 mm or Greater at 30 Minutes | Percentage of eyes achieving pupil diameter of 6.0 mm or greater | 30 minutes |
| 7.0 mm or Greater at 30 Minutes | Percentage of eyes achieving pupil diameter of 7.0 mm or greater |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Bennett, MS | Eyenovia Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY | New York | New York | 10036 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label Treatment | A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All subjects meeting inclusion/exclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Treatment | Single metered spray of MydCombi MydCombi: A single metered spray administered with the MydCombi dispenser |
| 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 | Mean Change in Pupil Diameter | Mean change in pupil diameter at 30 minutes from the time of drug dose versus baseline, as measured by digital pupillometry in highly photopic conditions | Posted | Mean | Standard Deviation | millimeters | 30 minutes | Eyes | Eyes |
|
|
6 hours
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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 | Open Label Treatment | A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greg M. Bennett, VP, Clinical Program Strategy and Development | Eyenovia | 833-393-6684 | 5 | gbennett@eyenovia.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2023 | Mar 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2024 | Mar 22, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014331 | Tropicamide |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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All subjects receive the same intervention
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| 30 minutes |
| Distribution of Pupil Diameters | Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes | 360 minutes |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | One subject declined to provide race | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Iris Color | Count of Participants | Participants |
|
| Eyes |
|
|
| Secondary | 6.0 mm or Greater at 30 Minutes | Percentage of eyes achieving pupil diameter of 6.0 mm or greater | Posted | Number | percentage of eyes >6.0 mm | 30 minutes | Eyes | Eyes |
|
|
|
| Secondary | 7.0 mm or Greater at 30 Minutes | Percentage of eyes achieving pupil diameter of 7.0 mm or greater | Posted | Number | percentage of eyes >7.0 mm | 30 minutes | Eyes | Eyes |
|
|
|
| Secondary | Distribution of Pupil Diameters | Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes | Posted | Mean | Standard Deviation | millimeters | 360 minutes | Eyes | Eyes |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
| Instillation Site Pain | Eye disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| 60 minutes |
|
| 90 Minutes |
|
| 150 Minutes |
|
| 210 Minutes |
|
| 360 Minutes |
|