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MydriasisPhase 3MIRA-3NCT05134974

Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis (MIRA-3)

A Phase 3 study testing Phentolamine Ophthalmic Solution 0.75% in people with Mydriasis and Dilation, run by Opus Genetics, Inc at 15 sites 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

The objectives of this study are: To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents… Read more about this study

Who is it for?
Ages 12 years and olderHealthy 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
368 participants
Where
15 sitesUnited States
Study dates
18 Nov 2021to 29 Mar 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 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Males or females ≥ 12 years of age
  • Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits

Who cannot join

  • Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, ocular surgery, or non-refractive laser treatment 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, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
  • 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 13Show fewer
  • Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
  • Prior participation in a study involving the use of Nyxol for the reversal of mydriasis
  • Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
  • Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
  • Participation in any investigational study within 30 days prior to screening
  • Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit.
  • Hypertension with resting diastolic blood pressure (BP)>105 mmHg or systolic BP > 160 mmHg at the Screening Visit.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Clinical Site 4

    Athens, Ohio, 45701

  • Clinical Site 2

    Bloomington, Minnesota, 55420

  • Clinical Site 9

    Delray Beach, Florida, 33484

  • Clinical Site 15

    Garner, North Carolina, 27529

  • Clinical Site 13

    Lake Villa, Illinois, 60046

  • Clinical Site 8

    Longwood, Florida, 32779

  • Clinical Site 3

    Memphis, Tennessee, 38119

  • Clinical Site 6

    Morrow, Georgia, 30260

  • Clinical Site 10

    Newport Beach, California, 92663

  • Clinical Site 5

    Pittsburg, Kansas, 66762

  • Clinical Site 1

    Roswell, Georgia, 30009

  • Clinical Site 14

    Shrewsbury, Pennsylvania, 17349

  • Clinical Site 11

    Sioux Falls, South Dakota, 57101

  • Clinical Site 7

    Warwick, Rhode Island, 02888

  • Clinical Site 12

    Westminster, California, 92655

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 Subjects

The objectives of this study are:

  • To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine
  • To evaluate the efficacy of Nyxol to return subjects to baseline accommodation after worsening (with cycloplegic agents tropicamide and Paremyd)
  • To evaluate the safety of Nyxol
  • To evaluate any additional benefits of the reversal of pharmacologically-induced mydriasis
  • To evaluate the systemic exposure of Nyxol on pharmacokinetic (PK) sampling
Read the detailed description

A randomized, parallel arm, double-masked, placebo-controlled Phase 3 study in at least 330 randomized subjects, evaluating the safety and efficacy of Nyxol in subjects with pharmacologically-induced mydriasis.

Following the successful completion of screening, each subject will be stratified by eye color and then simultaneously be randomized to mydriatic agent (unmasked) and treatment (masked). Treatment randomization will be 2:1, Nyxol or placebo (vehicle). Stratification by iris color will be 1:1, light or dark rides. The mydriatic agent randomization will be 3:1:1 (2.5% phenylephrine, 1% tropicamide, and Paremyd).

At the treatment visit, subjects who have been randomized and stratified by iris color (1:1 [light/dark]) will receive one of three approved mydriatic agents approximately 1 hour prior to receiving study treatment. Measurements will be measured before (-1 hour /baseline) and 60 minutes after (maximum/0 minutes) the mydriatic agent instillation in each eye (i.e. right before the study treatment is administered), and at 30 minutes, 60 minutes, 90 minutes, 2 hours, 3 hours, 4 hours, and 6 hours after treatment dosing. Measurements will include pupil diameter (PD), distance and near visual acuity (VA), accommodation, and redness in each eye.

Blood sampling for Nyxol PK measurements will be conducted in a subset of approximately 30 adult subjects at approximately two select study sites.

At the Follow-Up Visit, which is 1 day after Visit 1, measurements will again be recorded 24 hours after treatment dosing.

Conditions
Mydriasis, Dilation
Being tested
Phentolamine Ophthalmic Solution 0.75%, Phentolamine Ophthalmic Solution Vehicle
Keywords
Nyxol, Pharmacologically Induced Mydriasis, Dilation
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 NCT05134974
Study groupRoleWhat they receive
Phentolamine Ophthalmic Solution 0.75%Active comparator2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Receives: Drug: Phentolamine Ophthalmic Solution 0.75%
Phentolamine Ophthalmic Solution VehiclePlacebo comparator2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis
Receives: Drug: Phentolamine Ophthalmic Solution Vehicle

What is being measured

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

  1. Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

    Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter

    Measured: 90 minutes

Secondary outcomes (4)

  1. Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

    Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter

    Measured: 30 minutes to 24 hours

  2. Pupil Diameter (Change From Max)

    Change (mm) from maximum pharmacologically-induced mydriatic pupil diameter (0 minutes)

    Measured: 30 minutes to 24 hours

  3. Percent of Subjects With Unchanged Accommodation From Baseline

    Percentage of subjects with unchanged accommodation from baseline (-1 hour)

    Measured: 90 minutes to 6 Hours

  4. Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions

    Change from Baseline in best-corrected distance visual acuity (BCDVA) under normal photopic lighting without glare conditions

    Measured: 6 hours

Timeline

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

  1. First posted26 Nov 2021
  2. Study start18 Nov 2021
  3. Primary completion18 Mar 2022
  4. Study completion29 Mar 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
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05134974
Sponsor's protocol ID
OPI-NYXRM-302 (MIRA-3)
Acronym
MIRA-3
Status last verified
Aug 2023
First submitted
16 Nov 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 15 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 2 inclusion and 13 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 15 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 1 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?

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline (time frame: 90 minutes). 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 NCT05134974, 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.

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