Trial Outcomes & Findings for Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation (NCT NCT06217796)

NCT ID: NCT06217796

Last Updated: 2024-04-18

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2024-04-18

Participant Flow

Participant milestones

Measure	Open Label Treatment A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject declined to provide race

Baseline characteristics by cohort

Measure	Open Label Treatment n=29 Participants Single metered spray of MydCombi MydCombi: A single metered spray administered with the MydCombi dispenser
Age, Continuous	36.4 years n=29 Participants
Sex: Female, Male Female	15 Participants n=29 Participants
Sex: Female, Male Male	14 Participants n=29 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=29 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) Asian	9 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) Black or African American	7 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) White	11 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) More than one race	1 Participants n=28 Participants • One subject declined to provide race
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=28 Participants • One subject declined to provide race
Region of Enrollment United States	29 participants n=29 Participants
Iris Color Blue Iris	2 Participants n=29 Participants
Iris Color Brown Iris	26 Participants n=29 Participants
Iris Color Green Iris	1 Participants n=29 Participants
Iris Color Hazel Iris	0 Participants n=29 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Open Label Treatment n=58 Eyes A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
Mean Change in Pupil Diameter Change from Baseline	3.73 millimeters Standard Deviation 1.293
Mean Change in Pupil Diameter Pupil Diameter	6.46 millimeters Standard Deviation 1.411

SECONDARY outcome

Timeframe: 30 minutes

Percentage of eyes achieving pupil diameter of 6.0 mm or greater

Outcome measures

Measure	Open Label Treatment n=58 Eyes A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
6.0 mm or Greater at 30 Minutes	67.2 percentage of eyes >6.0 mm

SECONDARY outcome

Timeframe: 30 minutes

Percentage of eyes achieving pupil diameter of 7.0 mm or greater

Outcome measures

Measure	Open Label Treatment n=58 Eyes A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
7.0 mm or Greater at 30 Minutes	43.1 percentage of eyes >7.0 mm

SECONDARY outcome

Timeframe: 360 minutes

Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes

Outcome measures

Measure	Open Label Treatment n=58 Eyes A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
Distribution of Pupil Diameters Baseline	2.73 millimeters Standard Deviation 0.446
Distribution of Pupil Diameters 15 Minutes	4.80 millimeters Standard Deviation 1.335
Distribution of Pupil Diameters 30 Minutes	6.46 millimeters Standard Deviation 1.411
Distribution of Pupil Diameters 60 minutes	6.95 millimeters Standard Deviation 1.255
Distribution of Pupil Diameters 90 Minutes	6.70 millimeters Standard Deviation 1.249
Distribution of Pupil Diameters 150 Minutes	6.09 millimeters Standard Deviation 1.360
Distribution of Pupil Diameters 360 Minutes	3.51 millimeters Standard Deviation 0.774
Distribution of Pupil Diameters 210 Minutes	5.18 millimeters Standard Deviation 1.334

Adverse Events

Open Label Treatment

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Open Label Treatment n=30 participants at risk A single metered spray of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray)1%/2.5%
Eye disorders Dry Eye	3.3% 1/30 • Number of events 1 • 6 hours
Eye disorders Instillation Site Pain	10.0% 3/30 • Number of events 3 • 6 hours

Additional Information

Greg M. Bennett, VP, Clinical Program Strategy and Development

Eyenovia

Phone: 833-393-6684

Email: gbennett@eyenovia.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place