MydriasisPhase 3MIST-1NCT03751631

Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation

A Phase 3 study testing Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Tropicamide 1% ophthalmic solution (TR) and Phenylephrine 2.5% ophthalmic solution (PE) in people with Mydriasis, run by Eyenovia Inc. at 1 site in United States.

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

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Mydriasis
What is being tested?: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Tropicamide 1% ophthalmic solution (TR) and Phenylephrine 2.5% ophthalmic solution (PE)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2018to 11 Jan 2019
Phase: Phase 3
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Ability to provide written consent and return for all study visits
Photopic pupil diameter <= 3.5 mm in each eye

Who cannot join

Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
History of benign prostatic hyperplasia
Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
History of closed-angle glaucoma
Anatomically narrow anterior chamber angles
Ocular surgery or laser treatment of any kind

Show all 18Show fewer

History of chronic or acute uveitis
History of traumatic iritis or hyphema
History of traumatic mydriasis or angle recession
History of heterochromia
Irregularly-shaped pupil secondary to ocular trauma or congenital defect.
History of neurogenic pupil disorder
History of anterior chamber intraocular lens (IOL) or iris-fixated IOL
History of iris surgery, iris atrophy, or iris-cornea apposition/touch
Unwilling or unable to discontinue use of contact lenses at treatment visits.
Current active eye disease for which topical or systemic ophthalmic medication is necessary, except for dry eye disease managed using artificial tears.
Presence of a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment and/or follow-up
Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

United States1 site

WCCT
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Double-Masked, Active-Controlled Study of the Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil

This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PE) vs. phenylephrine (PE) alone and tropicamide (TR) alone. Participants attended 3 visits. At each visit, after baseline measurements, 1 of the 3 drugs was administered to both eyes, then pupil dilation and safety assessments were performed at specific time intervals.

Read the detailed description

Volunteer participants were screened for study eligibility during a Screening Visit and enrolled after signing the study-specific informed consent form. Subjects meeting all inclusion/exclusion criteria were scheduled for 3 treatment visits, which were at least 2 days, but no more than 7 days apart. At each treatment visit, baseline measurements were taken, then 1 of the 3 study drugs was administered to both eyes (each participant's drug administration sequence was randomly determined). Afterwards, efficacy and safety assessments were performed at 20, 35, 50, 65, 80, 120, and 180 minutes.

Conditions: Mydriasis
Being tested: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Tropicamide 1% ophthalmic solution (TR), Phenylephrine 2.5% ophthalmic solution (PE)
Medical subject headings: Mydriasis

What participants receive

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

Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)Drug
Also called Mydcombi
Fixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser
Tropicamide 1% ophthalmic solution (TR)Drug
Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser
Phenylephrine 2.5% ophthalmic solution (PE)Drug
Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser

Study groups in NCT03751631
Study group	Role	What they receive
1-TR/PE, 2-TR, 3-PE	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)
1-TR/PE, 2-PE, 3-TR	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)
1-TR, 2-TR/PE, 3-PE	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)
1-TR, 2-PE, 3-TR/PE	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)
1-PE, 2-TR/PE, 3-TR	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)
1-PE, 2-TR, 3-TR/PE	Other	Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye. Receives: Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE); Drug: Tropicamide 1% ophthalmic solution (TR); Drug: Phenylephrine 2.5% ophthalmic solution (PE)

What is being measured

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

Change in Pupil Diameter From Baseline
Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions.
Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome.
Measured: 35 minutes after initial dose

Timeline

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

15 Nov 201811 Jan 2019

First posted23 Nov 2018
Study start15 Nov 2018
Primary completion11 Jan 2019
Study completion11 Jan 2019

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.
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 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Model description: This trial was a double-masked, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03751631
Sponsor's protocol ID: EYN-MYD-TP-31
Acronym: MIST-1
Status last verified: Jan 2022
First submitted: 14 Nov 2018
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Masked, Active-Controlled Study of the Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution Administered With a Microdose Dispenser for Dilation of the Pupil
ClinicalTrials.gov ID: NCT03751631
Acronym / sponsor ID: MIST-1 / EYN-MYD-TP-31
Conditions: Mydriasis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Eyenovia Inc.Industry (pharma, biotech, devices)
Study start: 15 Nov 2018 (actual)
Primary completion: 11 Jan 2019 (actual)
Study completion: 11 Jan 2019 (actual)
First posted: 23 Nov 2018 (actual)
Results: Posted 18 Mar 2022

Clinical summary

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6
Model description: This trial was a double-masked, active-controlled, cross-over superiority study evaluating the efficacy of the fixed combination drug vs. the drug's 2 individual components. All participants in the trial were to receive each of the 3 drugs.

Arm	Type	Receives
1-TR/PE, 2-TR, 3-PE	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
1-TR/PE, 2-PE, 3-TR	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
1-TR, 2-TR/PE, 3-PE	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
1-TR, 2-PE, 3-TR/PE	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
1-PE, 2-TR/PE, 3-TR	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.
1-PE, 2-TR, 3-TR/PE	Other	Drug: Tropicamide 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE), Drug: Tropicamide 1% ophthalmic solution (TR), Drug: Phenylephrine 2.5% ophthalmic solution (PE)Participants were dosed once at 3 separate clinic visits in accordance with this sequence. Each participant received 2 sprays of the study drug in each eye.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Ability to provide written consent and return for all study visits
Photopic pupil diameter <= 3.5 mm in each eye

Key exclusion criteria (18 listed)

Allergy to phenylephrine hydrochloride, tropicamide, or benzalkonium chloride
History of benign prostatic hyperplasia
Use of a benzodiazepine, monoamine oxidase inhibitor, tricyclic antidepressant, anticonvulsant, or cholinergic drug
History of closed-angle glaucoma
Anatomically narrow anterior chamber angles

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 1%-Phenylephrine 2.5% ophthalmic solution (TR/PE)Also: MydcombiFixed combination tropicamide 1%-phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser	Drug	1-PE, 2-TR, 3-TR/PE, 1-PE, 2-TR/PE, 3-TR, 1-TR, 2-PE, 3-TR/PE, 1-TR, 2-TR/PE, 3-PE, 1-TR/PE, 2-PE, 3-TR, 1-TR/PE, 2-TR, 3-PE
Tropicamide 1% ophthalmic solution (TR)Tropicamide 1% ophthalmic solution administered with the Optejet microdose dispenser	Drug	1-PE, 2-TR, 3-TR/PE, 1-PE, 2-TR/PE, 3-TR, 1-TR, 2-PE, 3-TR/PE, 1-TR, 2-TR/PE, 3-PE, 1-TR/PE, 2-PE, 3-TR, 1-TR/PE, 2-TR, 3-PE
Phenylephrine 2.5% ophthalmic solution (PE)Phenylephrine 2.5% ophthalmic solution administered with the Optejet microdose dispenser	Drug	1-PE, 2-TR, 3-TR/PE, 1-PE, 2-TR/PE, 3-TR, 1-TR, 2-PE, 3-TR/PE, 1-TR, 2-TR/PE, 3-PE, 1-TR/PE, 2-PE, 3-TR, 1-TR/PE, 2-TR, 3-PE

Primary outcome

Change in Pupil Diameter From Baseline
Time frame: 35 minutes after initial dose
Difference in 35-minute pupil diameter vs. baseline measured using pupillometry in highly photopic conditions. Pupil diameter is reported in millimeters. For the change in pupil diameter, larger measurements indicate a better outcome.

Results and safety

Results posted to the registry on 18 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TR/PE - TR - PE	10	10
TR/PE - PE - TR	11	11
TR - TR/PE - PE	11	10
TR - PE - TR/PE	11	10
PE - TR/PE - TR	10	10
PE - TR - TR/PE	11	11

Primary outcome: Change in Pupil Diameter From Baseline

Time frame: 35 minutes after initial dose. Mean (Standard Deviation). Unit: millimeters

Measure	TR/PE - Right Eye n = 62	TR/PE - Left Eye n = 62	TR - Right Eye n = 62	TR - Left Eye n = 62	PE - Right Eye n = 62	PE - Left Eye n = 62
Baseline pupil diameter	2.672 (0.5673)	2.583 (0.4674)	2.657 (0.6016)	2.569 (0.5211)	2.651 (0.5749)	2.584 (0.5344)
35-minute pupil diameter	7.301 (0.8943)	7.329 (0.9771)	6.762 (0.8619)	6.690 (0.8682)	3.388 (0.8950)	3.552 (0.9340)
Change in 35-minute pupil diameter	4.629 (0.8343)	4.746 (0.8173)	4.105 (0.7207)	4.121 (0.6839)	0.737 (0.7939)	0.969 (0.8943)

Population analysed: Per-protocol population (participants who completed all planned assessments without a major protocol deviation)

Adverse events

Time frame: Adverse event data was collected over each subject's study participation period, which was a maximum of 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tropicamide/Phenylephrine	0 of 62 (0%)	2 of 62 (3.2%)	0 of 62
Tropicamide	0 of 64 (0%)	4 of 64 (6.3%)	0 of 64
Phenylephrine	0 of 62 (0%)	4 of 62 (6.5%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
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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?

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 2 inclusion and 18 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 18 Mar 2022. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Mar 2022). 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?

Change in Pupil Diameter From Baseline (time frame: 35 minutes after initial dose). 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 NCT03751631.

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 18 Mar 2022.