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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 minutes, 90 minutes, 3 hours, 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 minutes, 90 minutes, 3 hours, 24 hours
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.
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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