Mydriasis
Conditions
Keywords
Mydriasis
Brief summary
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
Detailed description
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.
Interventions
COMBINATION_PRODUCTMydCombi
A single metered spray administered with the MydCombi dispenser
Sponsors
Eyenovia Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects receive the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide signed written consent prior to participation in any study-related procedures. * Ability to return for the study treatment visit. * Photopic screening pupil diameter ≤ 3.5 mm in each eye. * Females not of childbearing potential or negative pregnancy test
Exclusion criteria
* Pregnant or Lactating * Clinically significant abnormalities of the eye * Active eye disease * Using medication that can effect pupil dilation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Pupil Diameter | 30 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6.0 mm or Greater at 30 Minutes | 30 minutes | Percentage of eyes achieving pupil diameter of 6.0 mm or greater |
| 7.0 mm or Greater at 30 Minutes | 30 minutes | Percentage of eyes achieving pupil diameter of 7.0 mm or greater |
| Distribution of Pupil Diameters | 360 minutes | Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Treatment Single metered spray of MydCombi
MydCombi: A single metered spray administered with the MydCombi dispenser | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Open Label Treatment |
|---|---|
| Age, Continuous | 36.4 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Iris Color Blue Iris | 2 Participants |
| Iris Color Brown Iris | 26 Participants |
| Iris Color Green Iris | 1 Participants |
| Iris Color Hazel Iris | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 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 | 11 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
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
Time frame: 30 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Treatment | Mean Change in Pupil Diameter | Change from Baseline | 3.73 millimeters | Standard Deviation 1.293 |
| Open Label Treatment | Mean Change in Pupil Diameter | Pupil Diameter | 6.46 millimeters | Standard Deviation 1.411 |
Secondary
6.0 mm or Greater at 30 Minutes
Percentage of eyes achieving pupil diameter of 6.0 mm or greater
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label Treatment | 6.0 mm or Greater at 30 Minutes | 67.2 percentage of eyes >6.0 mm |
Secondary
7.0 mm or Greater at 30 Minutes
Percentage of eyes achieving pupil diameter of 7.0 mm or greater
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Open Label Treatment | 7.0 mm or Greater at 30 Minutes | 43.1 percentage of eyes >7.0 mm |
Secondary
Distribution of Pupil Diameters
Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes
Time frame: 360 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Open Label Treatment | Distribution of Pupil Diameters | Baseline | 2.73 millimeters | Standard Deviation 0.446 |
| Open Label Treatment | Distribution of Pupil Diameters | 15 Minutes | 4.80 millimeters | Standard Deviation 1.335 |
| Open Label Treatment | Distribution of Pupil Diameters | 30 Minutes | 6.46 millimeters | Standard Deviation 1.411 |
| Open Label Treatment | Distribution of Pupil Diameters | 60 minutes | 6.95 millimeters | Standard Deviation 1.255 |
| Open Label Treatment | Distribution of Pupil Diameters | 90 Minutes | 6.70 millimeters | Standard Deviation 1.249 |
| Open Label Treatment | Distribution of Pupil Diameters | 150 Minutes | 6.09 millimeters | Standard Deviation 1.36 |
| Open Label Treatment | Distribution of Pupil Diameters | 210 Minutes | 5.18 millimeters | Standard Deviation 1.334 |
| Open Label Treatment | Distribution of Pupil Diameters | 360 Minutes | 3.51 millimeters | Standard Deviation 0.774 |