MydriasisPhase 4SPEEDNCT04907474

Evaluation of Pupil Dilation Speed With the MAP Dispenser

A Phase 4 study testing tropicamide-phenylephrine fixed combination ophthalmic solution in people with Mydriasis, run by Eyenovia Inc. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Mydriasis
What is being tested?: tropicamide-phenylephrine fixed combination ophthalmic solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteMexico
Study dates: 24 May 2021to 3 Jun 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

1. Photopic screening pupil diameter ≤ 3.5 mm in each eye

Who cannot join

Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
History of closed-angle glaucoma.
Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
Ocular surgery or laser treatment of any kind prior to the Screening Visit.
History of iris trauma, surgery, or atrophy.
Irregularly-shaped pupil secondary to ocular trauma or congenital defect, or history of neurogenic pupil disorder.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

CODET Vision Institute
Tijuana, Estado de Baja California, 22010

Other trials in Mexico

About this study

Official title: A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution

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

Read the detailed description

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.

Conditions: Mydriasis
Being tested: tropicamide-phenylephrine fixed combination ophthalmic solution
Medical subject headings: Mydriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tropicamide-phenylephrine fixed combination ophthalmic solutionDrug
Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis

Study groups in NCT04907474
Study group	Role	What they receive
Sequence AB	Other	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 Receives: Drug: tropicamide-phenylephrine fixed combination ophthalmic solution
Sequence BA	Other	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 Receives: Drug: tropicamide-phenylephrine fixed combination ophthalmic solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 35 minutes post drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 20213 Jun 2021

First posted28 May 2021
Study start24 May 2021
Primary completion3 Jun 2021
Study completion3 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MydriasisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Model description: All subjects received both treatments. Subjects were randomized to treatment order
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04907474
Sponsor's protocol ID: EYN-MYD-TP-41
Acronym: SPEED
Status last verified: Jan 2025
First submitted: 25 May 2021
Last updated: 9 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chayet A, Ramirez A, Scott B, Whitcomb J, Lam P, Ianchulev T. Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet(R). Ther Deliv. 2023 Feb;14(2):93-103. doi: 10.4155/tde-2022-0061. Epub 2023 May 9.
PubMed 37158245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Pupillary Dilation Reflex in Healthy Volunteers
Healthy Participants
Enrolling by invitation
Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Hearing Loss
Recruiting
Cochlear Implanted Listening Effort and Hearing Attention
Sensorineural Hearing Loss
Not yet recruitingObservational study
The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.
Pseudoexfoliation Syndrome

All Mydriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Evaluating Pupil Dilation Speed With the Micro-Array Print (MAP) Dispenser Comparing 2 Dosing Regimens of Tropicamide-Phenylephrine Fixed Combination Ophthalmic Solution
ClinicalTrials.gov ID: NCT04907474
Acronym / sponsor ID: SPEED / EYN-MYD-TP-41
Conditions: Mydriasis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Eyenovia Inc.Industry (pharma, biotech, devices)
Study start: 24 May 2021 (actual)
Primary completion: 3 Jun 2021 (actual)
Study completion: 3 Jun 2021 (actual)
First posted: 28 May 2021 (actual)
Results: Posted 9 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Pupil dilation for each treatment will be compared at each time interval.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: All subjects received both treatments. Subjects were randomized to treatment order

Arm	Type	Receives
Sequence AB	Other	Drug: tropicamide-phenylephrine fixed combination ophthalmic solutionSequence 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
Sequence BA	Other	Drug: tropicamide-phenylephrine fixed combination ophthalmic solutionSequence 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

1. Photopic screening pupil diameter ≤ 3.5 mm in each eye

Key exclusion criteria (7 listed)

Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride.
Use of benzodiazepines, monoamine oxidase inhibitors, tricyclic antidepressants, anticonvulsants, cholinergic drug at screening or anticipated during the study period.
History of closed-angle glaucoma.
Anatomically narrow anterior chamber angles (Van Herrick grade ≤ 2 in either eye).
Ocular surgery or laser treatment of any kind prior to the Screening Visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tropicamide-phenylephrine fixed combination ophthalmic solutionTropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis	Drug	Sequence AB, Sequence BA

Primary outcome

Mean Change in Pupil Diameter From Baseline
Time frame: 35 minutes post drug administration
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.

Results and safety

Results posted to the registry on 9 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Mist Then 2 Mists	31	30
2 Mists Then 1 Mist	30	30

Primary outcome: Mean Change in Pupil Diameter From Baseline

Time frame: 35 minutes post drug administration. Mean (Standard Deviation). Unit: millimeters

Measure	1 Mist n = 60	2 Mists n = 60
Value	4.55 (.68)	4.88 (.60)

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Mist Then 2 Mists	0 of 30 (0%)	0 of 30 (0%)	0 of 30
2 Mists Then 1 Mist	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37158245Chayet A, Ramirez A, Scott B, Whitcomb J, Lam P, Ianchulev T. Pupil dilation evaluation of two mydriatic dosing profiles delivered by the Optejet(R). Ther Deliv. 2023 Feb;14(2):93-103. doi: 10.4155/tde-2022-0061. Epub 2023 May 9.
Individual participant dataSharing planned: No

Related trials for Mydriasis

RecruitingObservational study
Pupillary Dilation Reflex in Healthy Volunteers
Healthy Participants
Enrolling by invitation
Pupillary Dilation During Post-Auricular Vagal Nerve Stimulation
Hearing Loss
Recruiting
Cochlear Implanted Listening Effort and Hearing Attention
Sensorineural Hearing Loss
Not yet recruitingObservational study
The Correlation Between Pupil Size and Retinal Nerve Fibers Changes in Pseudoexfoliation Syndrome.
Pseudoexfoliation Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tsontcho Ianchulev, MD, MPH study director

Eyenovia Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tropicamide-phenylephrine fixed combination ophthalmic solution in people with Mydriasis, run by Eyenovia Inc. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Pupil Diameter From Baseline (time frame: 35 minutes post drug administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04907474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.