AzTrials
AzTrials

MydriasisPhase 3MIRA-4NCT05223478

Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects

A Phase 3 study testing Phentolamine Ophthalmic Solution 0.75% in people with Mydriasis and Dilation, run by Opus Genetics, Inc at 2 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The objectives of this study are: To evaluate the safety of Nyxol in pediatric subjects To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication… Read more about this study

Who is it for?
Ages 3 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Mydriasis, Dilation
What is being tested?
Phentolamine Ophthalmic Solution 0.75%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
2 sitesUnited States
Study dates
17 Dec 2021to 28 Apr 2022
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 3 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Males or premenstrual females 3 to 11 years of age
  • Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
  • Parent/Legal guardian willing to give written informed consent to participate in this study. Children aged 7 to 11 years to provide signed assent form, as well as a separate parental/legal guardian consent.

Who cannot join

  • Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia, congenital cataract, congenital glaucoma) that might interfere with the study
  • Unwilling or unable to discontinue use of contact lenses at screening until study completion
  • Unwilling or unable to suspend use of topical medication at screening until study completion
  • Ocular trauma or ocular surgery within the 6 months prior to screening
  • Use of any topical prescription or over-the-counter (OTC)ophthalmic medications of any kind within 7 days of screening
  • Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
Show all 15Show fewer
  • Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
  • History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
  • Known allergy, hypersensitivity, or contraindication to any component of the phentolamine ophthalmic solution or to any component of the mydriatic agents or vehicle formulation
  • Systemic:
  • Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  • Clinically significant systemic disease (eg, uncontrolled diabetes, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator could interfere with the study
  • Subjects with learning disabilities that in the opinion of the investigator could interfere with the study
  • Initiation of treatment with or any changes to the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening or during the study(Appendix 4)
  • Participation in any investigational study within 30 days prior to screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Clinical Site 2

    Athens, Ohio, 45701

  • Clinical Site 1

    Longwood, Florida, 32779

Other trials in United States

About this study

Official title: Randomized, Parallel Arm, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically Induced Mydriasis in Healthy Pediatric Subjects

The objectives of this study are:

  • To evaluate the safety of Nyxol in pediatric subjects
  • To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol in pediatric subjects aged 3 to 11 for the indication "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."
Read the detailed description

This is a randomized, parallel-arm, double-masked, placebo-controlled study in approximately 20 randomized pediatric subjects evaluating the safety and efficacy of Nyxol in pediatric subjects with pharmacologically induced mydriasis with three dilating agents (e.g., phenylephrine, tropicamide, and Paremyd). Pediatric subjects will be recruited for the study into 2 age groups as follows:1) 3 to 5 years of age: 10 subjects 2) 6 to 11 years of age: 10 subjects.

Conditions
Mydriasis, Dilation
Being tested
Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle
Keywords
Nyxol, Pharmacologically Induced Mydriasis, Dilation, Pediatrics, Phentolamine, Mydriasis, Phenylephrine, Tropicamide, Paremyd
Medical subject headings
Mydriasis, Dilatation, Pathologic

What participants receive

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

  • Phentolamine Ophthalmic Solution 0.75%Drug

    Also called Nyxol®, Nyxol

    0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

  • Phentolamine Ophthalmic Solution VehicleDrug

    Phentolamine Ophthalmic Solution Vehicle

Study groups in NCT05223478
Study groupRoleWhat they receive
Phentolamine Ophthalmic Solution 0.75%Active comparatorOne drop of study medication in each eye.
Receives: Drug: Phentolamine Ophthalmic Solution 0.75%
Phentolamine Ophthalmic Solution VehiclePlacebo comparatorOne drop of study medication in each eye.
Receives: Drug: Phentolamine Ophthalmic Solution Vehicle

What is being measured

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

  1. Safety Measurements

    Study Eye Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 3, with 3 being considered the most severe.

    Measured: 0 Minutes, 90 Minutes, 3 Hours, 24 Hours

  2. Vital Signs

    Change from Screening Heart Rate

    Measured: 3 Hours, 24 Hours

  3. Vital Signs

    Change from Screening Blood Pressure (Systolic)

    Measured: 3 Hours, 24 Hours

  4. Safety Measurement

    Study Eye Change from Baseline (-1 Hour) in Best Corrected Distance Visual Acuity

    Measured: 0 Minutes, 3 Hours, 24 Hours

  5. Change From Screening Blood Pressure (Diastolic)

    Measured: 3 Hours, 24 Hours

Secondary outcomes (3)

  1. Efficacy Measurement: Pupil Diameter

    Percentage of Subjects Returning to ≤ 0.2 mm from Baseline (-1 hour) Pupil Diameter (Study Eye)

    Measured: 90 Minutes, 3 Hours, and 24 Hours

  2. Efficacy Measurement: Pupil Diameter

    Change (in mm) in Pupil Diameter from Max Pupil Dilation (0 minutes) (Study Eye)

    Measured: 90 Minutes, 3 Hours, and 24 Hours

  3. Efficacy Measurement: Pupil Diameter

    Time (Hours) to Return to ≤ 0.2 mm from Baseline (-1 Hour) Pupil Diameter (Time-savings Analysis) (Study Eye)

    Measured: Up to 24 Hours

Timeline

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

  1. First posted4 Feb 2022
  2. Study start17 Dec 2021
  3. Primary completion18 Apr 2022
  4. Study completion28 Apr 2022

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223478
Sponsor's protocol ID
OPI-NYXRMP-303 (MIRA-4)
Acronym
MIRA-4
Status last verified
Aug 2023
First submitted
16 Dec 2021
Last updated
30 Oct 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pepose JS, Foster S, Pearson C, Brigell M, Charizanis K. Reversal of Pharmacologic Mydriasis in Pediatric Subjects with Ryzumvi (0.75% Phentolamine Ophthalmic Solution): A Post-Hoc Pooled Analysis from Three Randomized, Placebo-Controlled Phase 3 Trials. Clin Ophthalmol. 2026 Feb 20;20:563499. doi: 10.2147/OPTH.S563499. eCollection 2026.

    PubMed 41743463

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phentolamine Ophthalmic Solution 0.75% in people with Mydriasis and Dilation, run by Opus Genetics, Inc at 2 sites 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 3 inclusion and 15 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 Aug 2023). 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?

Safety Measurements (time frame: 0 Minutes, 90 Minutes, 3 Hours, 24 Hours). The study lists 5 primary outcomes in all. 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 NCT05223478, 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 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in