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

NCT04620213 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: OPI-NYXRM-301 (MIRA-2)
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 12

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

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 (3)

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

  up to 24 hours

• Pupil Diameter (Change From Max)

  up to 24 hours

• Percent of Subjects With Unchanged Accommodation From Baseline

  up to 6 hours

Study Arms (2)

Phentolamine Ophthalmic Solution 0.75%

EXPERIMENTAL

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

Other: Phentolamine Ophthalmic Solution Vehicle (Placebo)

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 (Placebo) OTHER

Topical sterile ophthalmic solution

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
• Otherwise healthy and well controlled subjects

You may not qualify if:

• Ophthalmic (in either eye):
• Clinically significant ocular disease as deemed by the Investigator 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
• Recent or current evidence of ocular infection or inflammation in either eye
• History of diabetic retinopathy or diabetic macular edema
• Closed or very narrow angles that in the Investigator's opinion are 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 or contraindication to any component of the mydriatic agents or the vehicle formulation
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Systemic:
• Known hypersensitivity or contraindication to α- and/or β adrenoceptor antagonists.
• Clinically significant systemic disease that might interfere with the study

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (12)

Clinical Site 11

Newport Beach, California, 92663, United States

Location

Clinical Site 10

San Diego, California, 92123, United States

Location

Clinical Site 9

Longwood, Florida, 32779, United States

Location

Clinical Site 6

Orlando, Florida, 32751, United States

Location

Clinical Site 2

Roswell, Georgia, 30075, United States

Location

Clinical Site 7

Pittsburg, Kansas, 66762, United States

Location

Clinical Site 3

Shawnee Mission, Kansas, 66203, United States

Location

Clinical Site 5

Athens, Ohio, 45701, United States

Location

Clinical Site 12

Cincinnati, Ohio, 45242, United States

Location

Clinical Site 1

Cleveland, Ohio, 44195, United States

Location

Clinical Site 8

Warwick, Rhode Island, 02888, United States

Location

Clinical Site 4

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
• Organization: Ocuphire Pharma, Inc.

dcoleman@ocuphire.com

8134041993

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: November 18, 2020
• Primary Completion: December 23, 2020
• Study Completion: March 15, 2021
• Last Updated: September 11, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)