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

NCT05223478 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OPI-NYXRMP-303 (MIRA-4)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Nyxol; Pharmacologically Induced Mydriasis; Dilation; Pediatrics; Phentolamine; Mydriasis; Phenylephrine; Tropicamide; Paremyd

Outcome Measures

Primary Outcomes (5)

• Safety Measurements

  Study Eye Change from Baseline (-1 Hour) Conjunctival Hyperemia Grading; Cornea and Contact Lens Research Unit (CCLRU scale) Grades range from 0 to 3, with 3 being considered the most severe.

  0 Minutes, 90 Minutes, 3 Hours, 24 Hours

• Vital Signs

  Change from Screening Heart Rate

  3 Hours, 24 Hours

• Vital Signs

  Change from Screening Blood Pressure (Systolic)

  3 Hours, 24 Hours

• Safety Measurement

  Study Eye Change from Baseline (-1 Hour) in Best Corrected Distance Visual Acuity

  0 Minutes, 3 Hours, 24 Hours

• Change From Screening Blood Pressure (Diastolic)

  3 Hours, 24 Hours

Secondary Outcomes (3)

• Efficacy Measurement: Pupil Diameter

  90 Minutes, 3 Hours, and 24 Hours

• Efficacy Measurement: Pupil Diameter

  90 Minutes, 3 Hours, and 24 Hours

• Efficacy Measurement: Pupil Diameter

  Up to 24 Hours

Study Arms (2)

Phentolamine Ophthalmic Solution 0.75%

ACTIVE COMPARATOR

One drop of study medication in each eye.

Drug: Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

One drop of study medication in each eye.

Drug: Phentolamine Ophthalmic Solution Vehicle

Interventions

Phentolamine Ophthalmic Solution 0.75% DRUG

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

Also known as: Nyxol®, Nyxol

Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle DRUG

Phentolamine Ophthalmic Solution Vehicle

Phentolamine Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males or premenstrual females 3 to 11 years of age
• Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
• Parent/Legal guardian willing to give written informed consent to participate in this study. Children aged 7 to 11 years to provide signed assent form, as well as a separate parental/legal guardian consent.

You may not qualify if:

• Clinically significant ocular disease as deemed by the Investigator(eg, amblyopia, congenital cataract, congenital glaucoma) that might interfere with the study
• Unwilling or unable to discontinue use of contact lenses at screening until study completion
• Unwilling or unable to suspend use of topical medication at screening until study completion
• Ocular trauma or ocular surgery within the 6 months prior to screening
• Use of any topical prescription or over-the-counter (OTC)ophthalmic medications of any kind within 7 days of screening
• Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, or keratitis). Subjects must be symptom-free for at least 7 days prior to screening
• Closed or very narrow-angle that in the Investigator's opinion is potentially occludable if the subject's pupil is dilated
• History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine ophthalmic solution or to any component of the mydriatic agents or vehicle formulation
• Systemic:
• Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
• Clinically significant systemic disease (eg, uncontrolled diabetes, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that in the opinion of the Investigator could interfere with the study
• Subjects with learning disabilities that in the opinion of the investigator could interfere with the study
• Initiation of treatment with or any changes to the current dosage, drug, or regimen of any systemic adrenergic or cholinergic drugs within 7 days prior to screening or during the study(Appendix 4)
• Participation in any investigational study within 30 days prior to screening

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (2)

Clinical Site 1

Longwood, Florida, 32779, United States

Location

Clinical Site 2

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Mydriasis; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Pupil Disorders; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Drey Coleman VP of Clinical Operations
• Organization: Ocuphire

dcoleman@ocuphire.com

8134041993

Study Officials

• Charles Slonim, MD

  Oculos Development Services

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: February 4, 2022
• Study Start: December 17, 2021
• Primary Completion: April 18, 2022
• Study Completion: April 28, 2022
• Last Updated: September 5, 2023
• Results First Posted: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)