Trial Outcomes & Findings for Evaluation of Pupil Dilation Speed With the MAP Dispenser (NCT NCT04907474)

Last Updated: 2025-01-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

61 participants

Primary outcome timeframe

35 minutes post drug administration

Results posted on

2025-01-09

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	31	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Not eligible for study per Inc/Exc and was not treated. Not included in analysis.	1	0

Baseline Characteristics

Evaluation of Pupil Dilation Speed With the MAP Dispenser

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=60 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.
Age, Continuous	40.3 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Mexico	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 35 minutes post drug administration

Outcome measures

Outcome measures
Measure	1 Mist n=120 Eyes One mist 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	2 Mists n=120 Eyes 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
Mean Change in Pupil Diameter From Baseline	4.55 millimeters Standard Deviation .68	4.88 millimeters Standard Deviation .60

Adverse Events

1 Mist Then 2 Mists

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Mists Then 1 Mist

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Rowe

Eyenovia, Inc.

Phone: 833-393-6684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place