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NCT05134974: MIRA-3

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

Completed Phase 3 Results posted Last updated 29 August 2023
What this trial tests

Phase 3 trial testing Phentolamine Ophthalmic Solution 0.75% in Mydriasis in 368 participants. Completed in 29 March 2022.

Timeline
18 November 2021
Primary endpoint
18 March 2022
29 March 2022

Quick facts

Lead sponsorOcuphire Pharma, Inc.
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment368
Start date18 November 2021
Primary completion18 March 2022
Estimated completion29 March 2022
Sites15 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Ocuphire Pharma, Inc. — full company profile →

Who can join

12 and older, any sex, with Mydriasis or Dilation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline Primary · 90 minutes

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

GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%142
Phentolamine Ophthalmic Solution Vehicle7
Phentolamine Ophthalmic Solution 0.75%102
Phentolamine Ophthalmic Solution Vehicle117
Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline Secondary · 30 minutes to 24 hours

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

30 minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%10
Phentolamine Ophthalmic Solution Vehicle5
Phentolamine Ophthalmic Solution 0.75%234
Phentolamine Ophthalmic Solution Vehicle119
60 minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%103
Phentolamine Ophthalmic Solution Vehicle3
Phentolamine Ophthalmic Solution 0.75%141
Phentolamine Ophthalmic Solution Vehicle121
90 minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%142
Phentolamine Ophthalmic Solution Vehicle7
Phentolamine Ophthalmic Solution 0.75%102
Phentolamine Ophthalmic Solution Vehicle117
2 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%162
Phentolamine Ophthalmic Solution Vehicle9
Phentolamine Ophthalmic Solution 0.75%82
Phentolamine Ophthalmic Solution Vehicle115
3 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%193
Phentolamine Ophthalmic Solution Vehicle17
Phentolamine Ophthalmic Solution 0.75%51
Phentolamine Ophthalmic Solution Vehicle107
4 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%210
Phentolamine Ophthalmic Solution Vehicle21
Phentolamine Ophthalmic Solution 0.75%34
Phentolamine Ophthalmic Solution Vehicle103
6 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%221
Phentolamine Ophthalmic Solution Vehicle44
Phentolamine Ophthalmic Solution 0.75%23
Phentolamine Ophthalmic Solution Vehicle80
24 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%218
Phentolamine Ophthalmic Solution Vehicle89
Phentolamine Ophthalmic Solution 0.75%26
Phentolamine Ophthalmic Solution Vehicle35
Pupil Diameter (Change From Max) Secondary · 30 minutes to 24 hours

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

30 Minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-0.109± 0.7104
Phentolamine Ophthalmic Solution Vehicle0.092± 0.5335
60 Minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-1.457± 1.0825
Phentolamine Ophthalmic Solution Vehicle-0.059± 0.5775
90 Minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-2.157± 1.1911
Phentolamine Ophthalmic Solution Vehicle-0.284± 0.5852
2 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-2.478± 1.1453
Phentolamine Ophthalmic Solution Vehicle-0.488± 0.6807
3 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-2.917± 1.1721
Phentolamine Ophthalmic Solution Vehicle-0.987± 0.7932
4 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-3.078± 1.1578
Phentolamine Ophthalmic Solution Vehicle-1.261± 0.8615
6 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-3.267± 1.2743
Phentolamine Ophthalmic Solution Vehicle-1.755± 1.0205
24 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%-3.134± 1.3607
Phentolamine Ophthalmic Solution Vehicle-2.313± 1.3607
Percent of Subjects With Unchanged Accommodation From Baseline Secondary · 90 minutes to 6 Hours

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

90 Minutes
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%155
Phentolamine Ophthalmic Solution Vehicle65
Phentolamine Ophthalmic Solution 0.75%89
Phentolamine Ophthalmic Solution Vehicle59
2 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%165
Phentolamine Ophthalmic Solution Vehicle66
Phentolamine Ophthalmic Solution 0.75%79
Phentolamine Ophthalmic Solution Vehicle58
3 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%186
Phentolamine Ophthalmic Solution Vehicle81
Phentolamine Ophthalmic Solution 0.75%58
Phentolamine Ophthalmic Solution Vehicle43
6 Hours
GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%204
Phentolamine Ophthalmic Solution Vehicle86
Phentolamine Ophthalmic Solution 0.75%40
Phentolamine Ophthalmic Solution Vehicle38
Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions Secondary · 6 hours

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

GroupValue95% CI
Phentolamine Ophthalmic Solution 0.75%0.3± 3.73
Phentolamine Ophthalmic Solution Vehicle-0.2± 4.64

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 Days. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phentolamine Ophthalmic Solution 0.75%
Serious: 0/244 (0%)
Deaths: 0/244
Phentolamine Ophthalmic Solution Vehicle
Serious: 0/124 (0%)
Deaths: 0/124
Other adverse events (3 terms — click to expand)

ReactionSystemPhentolamine Ophthalmic So…Phentolamine Ophthalmic So…
Conjunctival HyperaemiaEye disorders——
Instillation site erythemaGeneral disorders——
DysgeusiaNervous system disorders——

Data from ClinicalTrials.gov NCT05134974 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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.
    Pepose JS, Foster S, Pearson C, Brigell M, et al · · 2026 · PMID 41743463 · DOI 10.2147/opth.s563499

Verify or expand the search:

Other trials of Phentolamine Ophthalmic Solution 0.75%

Trials testing the same drug.

Other Ocuphire Pharma, Inc. trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05134974.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing