A Phase 4 interventional study of tropicamide-phenylephrine fixed combination ophthalmic solution in Mydriasis, sponsored by Eyenovia Inc.. Completed at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Eyenovia Inc. · Phase 4, Interventional, and Diagnostic
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.
37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.
This study's enrollment of 61 is close to the median of 61 across 35 interventional studies indexed under Mydriasis.
Browse Mydriasis studies →Eyenovia Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
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
Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
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
Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis
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
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.
| Milestone | 1 Mist Then 2 Mists | 2 Mists Then 1 Mist |
|---|---|---|
| Started | 31 | 30 |
| Completed | 30 | 30 |
| Not completed | 1 | 0 |
| Withdrew: Not eligible for study per inc/exc and was not treated. not included in analysis. | 1 | 0 |
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.
| millimeters | 1 Mist | 2 Mists |
|---|---|---|
| Mean Change in Pupil Diameter From Baseline | 4.55 ± .68 | 4.88 ± .60 |
Collected over 7 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Mist Then 2 Mists | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| 2 Mists Then 1 Mist | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 40.3 ± 14.2 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 37 |
| Male | 23 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 59 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 60 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Participants |
|---|---|
| Mexico | 60 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Eyenovia Inc.