MydriasisPhase 4NCT06217796
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
A Phase 4 study testing MydCombi in people with Mydriasis, run by Eyenovia Inc. at 1 site in United States.
Trial summary
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mydriasis
- What is being tested?
- MydCombi
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2023to 9 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 childbearing potential or negative pregnancy test
Who cannot join
- Pregnant or Lactating
- Clinically significant abnormalities of the eye
- Active eye disease
- Using medication that can effect pupil dilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)
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.
- Conditions
- Mydriasis
- Being tested
- MydCombi
- Keywords
- Mydriasis
- Medical subject headings
- Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MydCombiCombination product
Also called tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%
A single metered spray administered with the MydCombi dispenser
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment | Other | Single metered spray Receives: Combination Product: MydCombi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (3)
6.0 mm or Greater at 30 Minutes
Percentage of eyes achieving pupil diameter of 6.0 mm or greater
Measured: 30 minutes
7.0 mm or Greater at 30 Minutes
Percentage of eyes achieving pupil diameter of 7.0 mm or greater
Measured: 30 minutes
Distribution of Pupil Diameters
Distribution of pupil diameters at 15, 30, 60, 90, 150, 210 and 360 minutes
Measured: 360 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start28 Nov 2023
- Primary completion9 Jan 2024
- Study completion9 Jan 2024
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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects receive the same intervention
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenovia Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Bennett, MS, Study director, Eyenovia Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217796
- Sponsor's protocol ID
- EYN-MYD-TP-41PM
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2024
- Last updated
- 18 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open Label, Phase 4 Study of the Safety and Efficacy of Fixed Combination Phenylephrine 2.5%-Tropicamide 1% Ophthalmic Solution (Mydcombi®) Administered With the Mydcombi Dispenser for Pupil Dilation (THE MIST-2.1 STUDY)
- ClinicalTrials.gov ID
- NCT06217796
- Acronym / sponsor ID
- EYN-MYD-TP-41PM
- Conditions
- Mydriasis
- Keywords
- Mydriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Eyenovia Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 9 Jan 2024 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Posted 18 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects receive the same intervention
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment | Other | Combination Product: MydCombiSingle metered spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 childbearing potential or negative pregnancy test
Key exclusion criteria (4 listed)
- Pregnant or Lactating
- Clinically significant abnormalities of the eye
- Active eye disease
- Using medication that can effect pupil dilation
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 |
|---|---|---|
| MydCombiAlso: tropicamide and phenylephrine hydrochloride ophthalmic spray 1%/2.5%A single metered spray administered with the MydCombi dispenser | Combination product | Open Label Treatment |
Primary outcome
Mean Change in Pupil Diameter
Time frame: 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
3 secondary outcomes
6.0 mm or Greater at 30 Minutes
Time frame: 30 minutes
7.0 mm or Greater at 30 Minutes
Time frame: 30 minutes
Distribution of Pupil Diameters
Time frame: 360 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
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.
Greg Bennett, MS 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 MydCombi in people with Mydriasis, run by Eyenovia Inc. at 1 site in United States.
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 4 inclusion and 4 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 Apr 2024. 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 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 18 Apr 2024). 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 (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2024.