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This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.
Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-TR/PE, 2-TR, 3-PE | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| 1-TR/PE, 2-PE, 3-TR | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| 1-TR, 2-TR/PE, 3-PE | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| 1-TR, 2-PE, 3-TR/PE | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE) | Drug | Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pupil Diameter From Baseline | Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome. | 35 minutes after initial dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication | The percent of eyes with pupil diameter 6.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tsontcho Ianchulev, MD, MPH | Eyenovia Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT | Cypress | California | 90630 | United States |
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64 of the 70 participants enrolled initiated treatment. Of those who did not initiate treatment, 4 failed to meet all study eligibility criteria, 1 was exited during screening due to behavioral issues, and 1 was exited after screening (before treatment) because the investigator believed the required number of subjects had initiated treatment.
70 patients signed the study informed consent form and were screened for eligibility between October 31, 2018 and November 16, 2018 at a clinical research center located in Cypress, California.
| ID | Title | Description |
|---|---|---|
| FG000 | TR/PE - TR - PE | Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Sep 21, 2018 | Jan 24, 2022 |
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This trial was a double-masked, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.
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There were no differences in the presentation of drug administered and all study personnel conducting ophthalmic assessments after drug administration were masked to treatment assignment.
| 1-PE, 2-TR/PE, 3-TR | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| 1-PE, 2-TR, 3-TR/PE | Other | Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. |
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| Tropicamide 1% ophthalmic solution (TR) | Drug | Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser |
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| Phenylephrine 2.5% ophthalmic solution (PE) | Drug | Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser |
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| 35 minutes after initial dose |
| Percentage of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication | The percent of eyes with pupil diameter 7.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome. | 35 minutes after initial dose |
| TR/PE - PE - TR |
Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser. |
| FG002 | TR - TR/PE - PE | Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser. |
| FG003 | TR - PE - TR/PE | Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Tropicamide 1%; 2nd Treatment Day - Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser. |
| FG004 | PE - TR/PE - TR | Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%; 3rd Treatment Day - Tropicamide 1%. Each drug was administered with the Optejet microdose dispenser. |
| FG005 | PE - TR - TR/PE | Participants were administered the assigned study drug in each eye on separate days in the following order: 1st Treatment Day - Phenylephrine 2.5%; 2nd Treatment Day - Tropicamide 1%; 3rd Treatment Day - Tropicamide 1%-Phenylephrine 2.5%. Each drug was administered with the Optejet microdose dispenser. |
| Received 1st Drug in Sequence |
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| Received 2nd Drug in Sequence |
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| Received 3rd Drug in Sequence |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants were administered each of the 3 assigned drugs on 3 separate days in the clinic (drug administration sequence was equally randomized across 6 possible administration sequences). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 |
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| Iris color category | Dark = Brown/black irides Light = All other colors | Count of Participants | Participants |
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| 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 | Change in Pupil Diameter From Baseline | Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome. | Per-protocol population (participants who completed all planned assessments without a major protocol deviation) | Posted | Mean | Standard Deviation | millimeters | 35 minutes after initial dose |
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| Other Pre-specified | Percentage of Eyes Achieving Pupil Diameter 6.0 mm or Larger After Receipt of Each Medication | The percent of eyes with pupil diameter 6.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome. | Per-protocol population (participants who completed all planned assessments without a major protocol deviation) | Posted | Number | percentage of eyes | 35 minutes after initial dose | Eyes | Eyes |
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| Other Pre-specified | Percentage of Eyes Achieving Pupil Diameter 7.0 mm or Larger After Receipt of Each Medication | The percent of eyes with pupil diameter 7.0 mm or larger as measured using pupillometry in highly photopic conditions. As this is a cross-over study, each of the 62 participants received each medication. Data is reported separately for the right and left eyes of the 62 participants. A higher percentage indicates a better outcome. | Per-protocol population (participants who completed all planned assessments without a major protocol deviation) | Posted | Number | percentage of eyes | 35 minutes after initial dose | Eyes | Eyes |
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Adverse event data was collected over each subject's study participation period, which was a maximum of 14 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 | Tropicamide/Phenylephrine | Tropicamide 1%/Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser | 0 | 62 | 0 | 62 | 2 | 62 |
| EG001 | Tropicamide | Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser | 0 | 64 | 0 | 64 | 4 | 64 |
| EG002 | Phenylephrine | Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser | 0 | 62 | 0 | 62 | 4 | 62 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Vital dye staining cornea present | Investigations | MedDRA 21.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 21.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Development | Eyenovia, Inc. | 714-269-8838 | gclasby@eyenoviabio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 7, 2019 | Jan 24, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2018 | Jan 24, 2022 | ICF_002.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 |
| D010656 | Phenylephrine |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 35-minute pupil diameter |
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| Change in 35-minute pupil diameter |
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| TR - Left Eye |
Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
| OG004 | PE - Right Eye | Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser |
| OG005 | PE - Left Eye | Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
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| TR - Left Eye |
Tropicamide 1% ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
| OG004 | PE - Right Eye | Phenylephrine 2.5% ophthalmic solution administered to the right eye with the Optejet microdose dispenser |
| OG005 | PE - Left Eye | Phenylephrine 2.5% ophthalmic solution administered to the left eye with the Optejet microdose dispenser |
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