Mydriasis
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGtropicamide-phenylephrine fixed combination ophthalmic solution
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis
Sponsors
Eyenovia Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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
Intervention model description
All subjects received both treatments. Subjects were randomized to treatment order
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1\. Photopic screening pupil diameter ≤ 3.5 mm in each eye
Exclusion criteria
1. Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride. 2. Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period. 3. History of closed-angle glaucoma. 4. Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye). 5. Ocular surgery or laser treatment of any kind prior to the Screening Visit. 6. History of iris trauma, surgery, or atrophy. 7. Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pupil Diameter From Baseline | 35 minutes post drug administration | 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. |
Countries
Mexico
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not eligible for study per Inc/Exc and was not treated. Not included in analysis. | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 60 Participants |
| Region of Enrollment Mexico | 60 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: 35 minutes post drug administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Mist | Mean Change in Pupil Diameter From Baseline | 4.55 millimeters | Standard Deviation 0.68 |
| 2 Mists | Mean Change in Pupil Diameter From Baseline | 4.88 millimeters | Standard Deviation 0.6 |