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

NCT05223478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-09-05

Study results available
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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."

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

Principal Investigators

  • Charles Slonim, MD · Oculos Development Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2022-04-18
Completion
2022-04-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05223478 on ClinicalTrials.gov