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

Completed · Phase 3 · Has a placebo group

Conditions studied: Presbyopia

In brief

Safety and efficacy of POS in participants with presbyopia

Key facts

Study ID

NCT06542497

Run by

Ocuphire Pharma, Inc.

People needed

569

Starts

2024-08-15

Expected to finish

2026-01-22

Last updated by the study team

2026-03-12

Who can join

Age: 45 and older, up to 64. Sex: any. Healthy volunteers: accepted.

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
• Inclusion criteria #5, #6, and #7 must all be met at both Screening and Baseline Visits:
• 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 topical prescription (including Vuity® or Qlosi™) or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) and artificial tears as specified in Exclusion Criterion #2 below
• 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
• Monofocal IOL in place > 6 months prior to Screening with any posterior capsule opacification
• History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris (eg, irregularly shaped pupil, neurogenic pupil disorder, iris atrophy, iridotomy, iridectomy, iritis, etc.)
• Unwilling or unable to discontinue use of contact lenses at least 1 hour prior to Screening for soft contact lenses or at least 8 hours prior to Screening for hard gas permeable contact lenses, and at least 8 hours (for both types of lenses) prior to all other office visits
• Systemic:
• Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists (eg, 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)
• Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent
• Clinically significant systemic disease (eg, uncontrolled diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study as deemed by the judgment of the Investigator
• 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; however, Flomax® (tamsulosin) is specifically excluded
• Participation in any investigational study within 30 days prior to Screening

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Carrot Eye Center — Mesa, Arizona, United States
• Eye Doctors of Arizona — Phoenix, Arizona, United States
• MRB Eye Care Consultants, LLC — Scottsdale, Arizona, United States
• Empire Eye & Laser Center — Bakersfield, California, United States
• Global Research Management, Inc. — Glendale, California, United States
• Gordon Schanzlin New Vision Institute — La Jolla, California, United States
• LoBue Laser and Eye Medical Center, Inc. — Murrieta, California, United States
• Eye Research Foundation — Newport Beach, California, United States
• Wolstan and Goldberg Eye Associates — Torrance, California, United States
• Segal Drug Trials, Inc. — Delray Beach, Florida, United States
• South Florida Glaucoma — Delray Beach, Florida, United States
• Levenson Eye — Jacksonville, Florida, United States
• Bowden Eye & Associates — Jacksonville, Florida, United States
• Shettle Eye Research — Largo, Florida, United States
• Sabal Eye Care/dba Omega Vision Center — Longwood, Florida, United States
• Mid Florida Eye Center — Mt. Dora, Florida, United States
• Virdi Eye Clinic — Rock Island, Illinois, United States
• Price Vision Group — Indianapolis, Indiana, United States
• Durrie Vision — Overland Park, Kansas, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• Heart of America Eye Care, P.A. — Shawnee Mission, Kansas, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Fraser Eye Care Center — Fraser, Michigan, United States
• Moyes Eye Center — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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