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1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
After screening, eligible subjects will be scheduled for 2 treatment visits where either 1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan. Safety evaluations and efficacy measurements will be performed at specified time intervals thereafter.
Pupil dilation for each treatment will be compared at each time interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Other | Sequence AB: 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser |
|
| Sequence BA | Other | Sequence BA: 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tropicamide-phenylephrine fixed combination ophthalmic solution | Drug | Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Pupil Diameter From Baseline | The primary performance endpoint is Mean Change in pupil diameter at 35 minutes versus per-visit baseline, as measured by digital pupillometry in highly photopic conditions. The highly photopic condition was established using a fully-charged transilluminator (muscle light) at the brightest setting. | 35 minutes post drug administration |
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Inclusion Criteria:
1. Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, MD, MPH | Eyenovia Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CODET Vision Institute | Tijuana | Estado de Baja California | 22010 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37158245 | Derived | Chayet A, Ramirez A, Scott B, Whitcomb J, Lam P, Ianchulev T. Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet(R). Ther Deliv. 2023 Feb;14(2):93-103. doi: 10.4155/tde-2022-0061. Epub 2023 May 9. |
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A total of 61 subjects were consented at a single-center and assessed for eligibility. A total of 60 subjects met eligibility criteria and were randomized. (1 consented subject was ineligible). All eligible subjects received both treatments.A total of 60 subjects completed the study. No subjects were lost to follow-up or were terminated early from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Mist Then 2 Mists | 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser |
| FG001 | 2 Mists Then 1 Mist | 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the Micro Array Print (MAP) Dispenser |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants were administered either 1 Mist/Eye or 2 Mists/Eye of the study drug on separate days in the clinic occurring at least 4 days, but no more than 7 days apart. |
| 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 From Baseline | The primary performance endpoint is Mean Change in pupil diameter at 35 minutes versus per-visit baseline, as measured by digital pupillometry in highly photopic conditions. The highly photopic condition was established using a fully-charged transilluminator (muscle light) at the brightest setting. | Posted | Mean | Standard Deviation | millimeters | 35 minutes post drug administration | Eyes | Eyes |
|
7 days
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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 | 1 Mist Then 2 Mists | 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser followed by 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Rowe | Eyenovia, Inc. | 833-393-6684 | mmrowe@eyenovia.com |
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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 | May 6, 2021 | Jun 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
| D005128 | Eye Diseases |
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All subjects received both treatments. Subjects were randomized to treatment order
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Only 1 mist or 2 mists of the drug will be administered per treatment visit and will occur in a randomized sequence order using on of the two sequences AB or BA where A is 1 mist of the fixed combination and B is 2 mists of the fixed combination
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Two mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser tropicamide-phenylephrine fixed combination ophthalmic solution: Tropicamide-phenylephrine fixed combination ophthalmic solution is a topical drug solution for mydriasis |
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 2 Mists Then 1 Mist | 2 mists of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser followed by 1 mist of tropicamide-phenylephrine fixed combination solution administered to each eye with the MAP Dispenser | 0 | 30 | 0 | 30 | 0 | 30 |
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