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Alpha-Adrenergic Blocker

Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects (MIRA-4 Trial)

Phase 3
Waitlist Available
Research Sponsored by Ocuphire Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 minutes, 90 minutes, 3 hours, 24 hours
Awards & highlights
Pivotal 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 "the treatment of pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or parasympatholytic (tropicamide) agents, or a combination thereof."

Eligible Conditions
  • Dilated Pupil
  • Dilatation
  • Iatrogenic Mydriasis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 minutes, 90 minutes, 3 hours, 24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 minutes, 90 minutes, 3 hours, 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety Measurement
Safety Measurements
Vital Signs
Secondary study objectives
Efficacy Measurement: Pupil Diameter

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Phentolamine Ophthalmic Solution 0.75%Active Control1 Intervention
One drop of study medication in each eye.
Group II: Phentolamine Ophthalmic Solution VehiclePlacebo Group1 Intervention
One drop of study medication in each eye.

Find a Location

Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
12 Previous Clinical Trials
2,183 Total Patients Enrolled
Charles Slonim, MDStudy DirectorOculos Development Services
1 Previous Clinical Trials
80 Total Patients Enrolled
~6 spots leftby Dec 2025