Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

NCT06542497 | Completed Phase 3 FDA Drug

• 1 other identifier: OPI-NYXP-302
• Study Type: interventional
• Target: 569
• Locations: 1 country
• Sites: 39

Brief Summary

Safety and efficacy of POS in participants with presbyopia

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Primary efficacy endpoint

  The primary efficacy endpoint is the percentage of participants with ≥ 15 letters of improvement in binocular DCNVA and with \< 5 letters of loss in binocular BCDVA from baseline comparing POS-treated participants to placebo-treated participants at 12 hours post-dose at Visit 4 (Day 8)

  Day 8

Study Arms (2)

0.75% phentolamine ophthalmic solution

ACTIVE COMPARATOR

Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist

Drug: 0.75% phentolamine ophthalmic solution

phentolamine ophthalmic solution vehicle

PLACEBO COMPARATOR

Drug: Placebo

Drug: Placebo

Interventions

0.75% phentolamine ophthalmic solution DRUG

Once daily dosing

Also known as: Nyxol

0.75% phentolamine ophthalmic solution

Placebo DRUG

Once daily dosing

Also known as: phentolamine ophthalmic solution vehicle

phentolamine ophthalmic solution vehicle

Eligibility Criteria

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

You may qualify if:

• Participants must meet all of the following criteria:
• Males or females ≥ 45 and ≤ 64 years of age
• Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits
• Able and willing to give signed informed consent
• Able to self-administer study medication throughout the study period
• BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye
• DCNVA of 50 ETDRS letters (20/50 Snellen equivalent) or worse but not \<35 ETDRS letters (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly
• For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better
• Photopic PD of ≥ 4 mm in the study eye at Screening

You may not qualify if:

• Excluded from the study will be individuals with any of the following characteristics:
• Ophthalmic (in either eye):
• Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication
• Use of Ryzumvi™ (POS) within 7 days prior to Screening
• Use of any dry eye product, such as topical ophthalmic therapy for dry eye (eg, generic cyclosporine, Restasis®, Xiidra®, Cequa®, Eysuvis®, and Meibo®) or intranasal dry eye product (eg, Tyrvaya®) or other devices within 12 months prior to Screening
• Tear break-up time of \< 5 seconds or corneal fluorescein staining (CFS) Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale
• Clinically significant ocular disease (eg, cataract, glaucoma, corneal edema, uveitis, retinal degeneration, loss of visual field, or any macular pathology) that, in the judgment of the Investigator, might interfere with study procedures
• Recent or current evidence of ocular infection or inflammation in either eye (such as current evidence of clinically significant blepharitis, conjunctivitis, keratitis, etc.). Participants must be symptom free for at least 7 days prior to Screening
• Any history of herpes simplex or herpes zoster keratitis
• Known allergy, hypersensitivity, or contraindication to any component of the phentolamine or vehicle formulations
• Prior participation in a study involving the use of POS for the treatment of presbyopia or night vision disturbance
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Ocular trauma within 6 months prior to Screening
• Ocular surgery or any ocular laser treatment within 6 months prior to Screening. Any history of radial keratotomy is prohibited
• Participants with surgical monovision, multifocal, or extended depth-of-focus intraocular lenses (IOLs). Monofocal IOLs are acceptable if in place \> 6 months prior to Screening

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead

Study Sites (39)

Arizona Eye Center

Chandler, Arizona, 85224, United States

Location

Carrot Eye Center

Mesa, Arizona, 85202, United States

Location

Eye Doctors of Arizona

Phoenix, Arizona, 85028, United States

Location

MRB Eye Care Consultants, LLC

Scottsdale, Arizona, 85260, United States

Location

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Global Research Management, Inc.

Glendale, California, 91204, United States

Location

Gordon Schanzlin New Vision Institute

La Jolla, California, 92307, United States

Location

LoBue Laser and Eye Medical Center, Inc.

Murrieta, California, 92562, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

Location

Segal Drug Trials, Inc.

Delray Beach, Florida, 33484, United States

Location

South Florida Glaucoma

Delray Beach, Florida, 33484, United States

Location

Levenson Eye

Jacksonville, Florida, 32204, United States

Location

Bowden Eye & Associates

Jacksonville, Florida, 32256, United States

Location

Shettle Eye Research

Largo, Florida, 33773, United States

Location

Sabal Eye Care/dba Omega Vision Center

Longwood, Florida, 32779, United States

Location

Mid Florida Eye Center

Mt. Dora, Florida, 32757, United States

Location

Virdi Eye Clinic

Rock Island, Illinois, 61201, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Durrie Vision

Overland Park, Kansas, 66210, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 66204, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Fraser Eye Care Center

Fraser, Michigan, 48026, United States

Location

Moyes Eye Center

Kansas City, Missouri, 64154, United States

Location

Rochester Ophthalmological Group

Rochester, New York, 14618, United States

Location

Oculus Research , Inc.

Garner, North Carolina, 27529, United States

Location

Bergstrom Eye

Fargo, North Dakota, 58103, United States

Location

Red River Research Partners

Fargo, North Dakota, 58103, United States

Location

Athens Eye Care

Athens, Ohio, 45701, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Advancing Vision Research

Goodlettsville, Tennessee, 37072, United States

Location

Optometry Group

Memphis, Tennessee, 38111, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Lake Travis Eye and Laser Center/ Revolution Research

Lakeway, Texas, 78738, United States

Location

Red River Research Partners

Richardson, Texas, 75080, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Jay V Pepose, MD

  Ocuphire Pharma

  STUDY CHAIR

Study Design

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

Model Details: Parallel assignment

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: August 15, 2024
• Primary Completion: April 3, 2025
• Study Completion: January 22, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (39)