Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis

NCT04024891 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: OPI-NYXRM-201 (MIRA-1)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

Brief Summary

The objectives of this study are:

• To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis
• To evaluate the safety of Nyxol
• To evaluate the effect of Lumify® to suppress conjunctival hyperemia (redness) potentially associated with administration of Nyxol

Conditions

Mydriasis; Dilation

Keywords

Nyxol; Pharmacologically Induced Mydriasis; Dilation

Outcome Measures

Primary Outcomes (1)

• Pupil Diameter (Change From Max)

  Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.

  2 hours

Secondary Outcomes (6)

• Pupil Diameter (Change From Max)

  30 min, 1 hours, 4 hours, 6 hours

• Pupil Diameter Return to Baseline

  0 min, 1 hour, 2 hours, 4 hours, 6 hours

• Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation

  0 min, 2 hours, 4 hours

• Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)

  0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours

• Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)

  0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours

Study Arms (2)

Phentolamine Mesylate Ophthalmic Solution 1%

EXPERIMENTAL

1 drop in each eye, 1 hour post medically-induced mydriasis

Drug: Phentolamine Mesylate Ophthalmic Solution 1%

Phentolamine Mesylate Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

1 drop in each eye, 1 hour post medically-induced mydriasis

Other: Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)

Interventions

Phentolamine Mesylate Ophthalmic Solution 1% DRUG

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

Also known as: Nyxol®, Nyxol

Phentolamine Mesylate Ophthalmic Solution 1%

Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo) OTHER

Topical Sterile Ophthalmic Solution

Phentolamine Mesylate Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females ≥ 18 and ≤ 45 years of age with brown irides (irises) only
• Otherwise healthy and well controlled subjects
• Able to comply with all protocol mandated procedures and to attend all scheduled office visits
• Willing to give written informed consent to participate in this study

You may not qualify if:

• Clinically significant ocular disease as deemed by the Investigator (e.g., cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca) that might interfere with the study
• Unwilling or unable to discontinue use of contact lenses during treatment visits
• Ocular trauma, ocular surgery or non-refractive laser treatment within the 6 months prior to screening
• Ocular medication of any kind within 30 days of screening, with the exception of a) lid scrubs (which may have been used prior to, but not after screening) or b) lubricating drops for dry eye (preservative-free artificial tears), which may be used in between the study treatment days
• Recent or current evidence of ocular infection or inflammation. Current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex or herpes zoster keratitis at screening
• History of diabetic retinopathy
• 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 (e.g., irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy)
• Known allergy or contraindication to any component of the mydriatic agents or the vehicle formulation
• Known hypersensitivity or contraindication to α- and/or β-adrenoceptor antagonists (e.g., chronic obstructive pulmonary disease or bronchial asthma; abnormally low blood pressure (BP) or heart rate (HR); second- or third-degree heart blockage or Congestive Heart Failure (CHF); severe diabetes)
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine or cardiovascular disorders) that might interfere with the study
• Initiation of treatment with or any changes to the current dosage, drug or regimen of any topical or systemic adrenergic or cholinergic drugs up to 7 days prior to screening, or during the study
• Participation in any investigational study within 30 days prior to screening
• Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at Visit 1/Screening and Visit 2 examinations and must intend to not become pregnant during the study
• Resting heart rate (HR) outside the normal range (50-110 beats per minute) at the Screening Visit. HR may be repeated only once if outside the normal range following at least a 5-minute rest period in the sitting position

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (4)

Kannar Eye Care

Pittsburg, Kansas, 66762, United States

Location

Kentucky Eye Institute

Lexington, Kentucky, 40517, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Related Publications (1)

• Karpecki PM, Foster SA, Montaquila SM, Kannarr SR, Slonim CB, Meyer AR, Sooch MP, Jaber RM, Charizanis K, Yousif JE, Klapman SA, Amin AT, McDonald MB, Horn GD, Lazar ES, Pepose JS. Phentolamine Eye Drops Reverse Pharmacologically Induced Mydriasis in a Randomized Phase 2b Trial. Optom Vis Sci. 2021 Mar 1;98(3):234-242. doi: 10.1097/OPX.0000000000001656.

  PMID: 33633016 DERIVED

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 18, 2019
• Study Start: August 13, 2019
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: August 29, 2023
• Results First Posted: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)