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

NCT05134974 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OPI-NYXRM-302 (MIRA-3)
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 15

Brief 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

Keywords

Nyxol; Pharmacologically Induced Mydriasis; Dilation

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

  Percentage of subjects' study eyes returning to less than or equal to 0.2 mm from baseline pupil diameter

  90 minutes

Secondary Outcomes (4)

• Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

  30 minutes to 24 hours

• Pupil Diameter (Change From Max)

  30 minutes to 24 hours

• Percent of Subjects With Unchanged Accommodation From Baseline

  90 minutes to 6 Hours

• Change From Baseline in Best-Corrected Distance Visual Acuity (BCDVA) Under Normal Photopic Lighting Without Glare Conditions

  6 hours

Study Arms (2)

Phentolamine Ophthalmic Solution 0.75%

ACTIVE COMPARATOR

2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis

Drug: Phentolamine Ophthalmic Solution 0.75%

Phentolamine Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

2 drops in study eye and 1 drop in non-study eye, 1 hour post pharmacologically-induced mydriasis

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: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 12 years of age
• Ability to comply with all protocol-mandated procedures independently and to attend all scheduled office visits

You may not qualify if:

• Clinically significant ocular disease as deemed by the Investigator (eg, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) 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, ocular surgery, or non-refractive laser treatment 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, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.)
• 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
• Prior participation in a study involving the use of Nyxol for the reversal of mydriasis
• Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists
• Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study
• Participation in any investigational study within 30 days prior to screening
• Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit.
• Hypertension with resting diastolic blood pressure (BP)\>105 mmHg or systolic BP \> 160 mmHg at the Screening Visit.

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (15)

Clinical Site 10

Newport Beach, California, 92663, United States

Location

Clinical Site 12

Westminster, California, 92655, United States

Location

Clinical Site 9

Delray Beach, Florida, 33484, United States

Location

Clinical Site 8

Longwood, Florida, 32779, United States

Location

Clinical Site 6

Morrow, Georgia, 30260, United States

Location

Clinical Site 1

Roswell, Georgia, 30009, United States

Location

Clinical Site 13

Lake Villa, Illinois, 60046, United States

Location

Clinical Site 5

Pittsburg, Kansas, 66762, United States

Location

Clinical Site 2

Bloomington, Minnesota, 55420, United States

Location

Clinical Site 15

Garner, North Carolina, 27529, United States

Location

Clinical Site 4

Athens, Ohio, 45701, United States

Location

Clinical Site 14

Shrewsbury, Pennsylvania, 17349, United States

Location

Clinical Site 7

Warwick, Rhode Island, 02888, United States

Location

Clinical Site 11

Sioux Falls, South Dakota, 57101, United States

Location

Clinical Site 3

Memphis, Tennessee, 38119, 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

813-404-1993

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: November 16, 2021
• First Posted: November 26, 2021
• Study Start: November 18, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 29, 2022
• Last Updated: August 29, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)