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

NCT05134974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2023-08-29

Study results available
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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 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

Conditions

  • Mydriasis
  • Dilation

Interventions

DRUG

Phentolamine Ophthalmic Solution 0.75%

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

DRUG

Phentolamine Ophthalmic Solution Vehicle

Phentolamine Ophthalmic Solution Vehicle

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2022-03-18
Completion
2022-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134974 on ClinicalTrials.gov