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CompletedNCT06217796Updated Apr 18, 2024Results posted

Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation

A Phase 4 interventional study of MydCombi in Mydriasis, sponsored by Eyenovia Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Eyenovia Inc. · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.

Read the 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.

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Conditions studied

  • Mydriasis

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Keywords

  • Mydriasis
03

In context

Mydriasis

37 studies on the registry are indexed under Mydriasis; 4 are open to participants now.

This study's enrollment of 30 is below the median of 61 across 35 interventional studies indexed under Mydriasis.

Browse Mydriasis studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 or negative pregnancy test

Exclusion criteria

Exclusion Criteria:

  • Pregnant or Lactating
  • abnormalities of the eye
  • Active eye disease
  • Using medication that can effect pupil dilation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    Open Label Treatment

    Single metered spray

    Combination Product: MydCombi

Interventions

  • Combination productMydCombi

    A single metered spray administered with the MydCombi dispenser

    Also known as: tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 6.0 mm or Greater at 30 Minutes

    Percentage of eyes achieving pupil diameter of 6.0 mm or greater

    Time frame: 30 minutes

  2. 7.0 mm or Greater at 30 Minutes

    Percentage of eyes achieving pupil diameter of 7.0 mm or greater

    Time frame: 30 minutes

  3. Distribution of Pupil Diameters

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

    Time frame: 360 minutes

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Results

Posted Apr 18, 2024

Participant flow

Participant flow — Overall Study
MilestoneOpen Label Treatment
Started30
Completed30
Not completed0

Outcome measures

PrimaryMean 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
Reported as:
Mean · millimeters
Mean Change in Pupil Diameter
millimetersOpen Label Treatment
Change from Baseline3.73 ± 1.293
Pupil Diameter6.46 ± 1.411
Secondary6.0 mm or Greater at 30 Minutes

Percentage of eyes achieving pupil diameter of 6.0 mm or greater

Time frame:
30 minutes
Reported as:
Number · percentage of eyes >6.0 mm
6.0 mm or Greater at 30 Minutes
percentage of eyes >6.0 mmOpen Label Treatment
6.0 mm or Greater at 30 Minutes67.2
Secondary7.0 mm or Greater at 30 Minutes

Percentage of eyes achieving pupil diameter of 7.0 mm or greater

Time frame:
30 minutes
Reported as:
Number · percentage of eyes >7.0 mm
7.0 mm or Greater at 30 Minutes
percentage of eyes >7.0 mmOpen Label Treatment
7.0 mm or Greater at 30 Minutes43.1
SecondaryDistribution of Pupil Diameters

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

Time frame:
360 minutes
Reported as:
Mean · millimeters
Distribution of Pupil Diameters
millimetersOpen Label Treatment
Baseline2.73 ± 0.446
15 Minutes4.80 ± 1.335
30 Minutes6.46 ± 1.411
60 minutes6.95 ± 1.255
90 Minutes6.70 ± 1.249
150 Minutes6.09 ± 1.360
210 Minutes5.18 ± 1.334
360 Minutes3.51 ± 0.774

Adverse events

Collected over 6 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Label Treatment0/30 (0%)0/30 (0%)3/30 (10%)
Most frequent other events
Most frequent other events
EventOpen Label Treatment
Instillation Site PainEye disorders3/30
Dry EyeEye disorders1/30

Baseline characteristics

All subjects meeting inclusion/exclusion criteria

Age, Continuous
Age, Continuous(years)Open Label Treatment
Mean36.4 (20 to 63)
Sex: Female, Male
Sex: Female, Male(Participants)Open Label Treatment
Female15
Male14
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Open Label Treatment
Hispanic or Latino7
Not Hispanic or Latino22
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Open Label Treatment
American Indian or Alaska Native0
Asian9
Native Hawaiian or Other Pacific Islander0
Black or African American7
White11
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Open Label Treatment
United States29
Iris Color
Iris Color(Participants)Open Label Treatment
Blue Iris2
Brown Iris26
Green Iris1
Hazel Iris0
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Study locations

1 site
  • SUNY
    New York, New York 10036, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Jan 2024, 1 month.

Results were first posted in Apr 2024, 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2024
First posted
Jan 22, 2024
StartActual
Nov 28, 2023
Primary completionActual
Jan 9, 2024
CompletionActual
Jan 9, 2024
Results first posted
Apr 18, 2024
Last update
Apr 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06217796
Lead sponsor
Eyenovia Inc.
Responsible party
Sponsor
First posted
Jan 22, 2024
Start date
Nov 28, 2023
Primary completion
Jan 9, 2024
Completion
Jan 9, 2024
Results posted
Apr 18, 2024
Last update
Apr 18, 2024

Study contacts

Greg Bennett, MS
study director · Eyenovia Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

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