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

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified January 2026 by Ocuphire Pharma, Inc.
Sponsor
Ocuphire Pharma, Inc.
Information Provided by (Responsible Party)
Ocuphire Pharma, Inc.
Clinicaltrials.gov Identifier
NCT06542497
Other Study ID Numbers:
OPI-NYXP-302
First Submitted
August 4, 2024
First Posted
August 6, 2024
Last Update Posted
March 11, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia

Condition or DiseaseIntervention/Treatment
Presbyopia
Drug: 0.75% phentolamine ophthalmic solutionDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment569 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleRandomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia
Study Start DateAugust 14, 2024
Actual Primary Completion DateApril 2, 2025
Actual Study Completion DateJanuary 21, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
0.75% phentolamine ophthalmic solution
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Drug: 0.75% phentolamine ophthalmic solution
Once daily dosing
phentolamine ophthalmic solution vehicle
Drug: Placebo
Drug: Placebo
Once daily dosing

Outcome Measures

Primary Outcome Measures
  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)

Eligibility Criteria

Ages Eligible for Study(Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersYes
Inclusion Criteria
Participants must meet all of the following criteria: 1. Males or females ≥ 45 and ≤ 64 years of age 2. Able to comply with all protocol-mandated procedures independently and to attend all scheduled office visits 3. Able and willing to give signed informed consent 4. 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: 5. BCDVA of 55 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/20 Snellen equivalent) or better in photopic conditions in each eye 6. 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 7. For participants who depend on reading glasses or bifocals, binocular best-corrected near VA of 65 ETDRS letters (20/25 Snellen equivalent) or better 8. Photopic PD of ≥ 4 mm in the study eye at Screening
Exclusion Criteria
Excluded from the study will be individuals with any of the following characteristics: Ophthalmic (in either eye): 1. 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 2. Use of any OTC artificial tears (preserved or unpreserved) during visit days or 15 min before or after instillation of study medication 3. Use of Ryzumvi™ (POS) within 7 days prior to Screening 4. 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 5. 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 6. 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 7. 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 8. Any history of herpes simplex or herpes zoster keratitis 9. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine or vehicle formulations 10. Prior participation in a study involving the use of POS for the treatment of presbyopia or night vision disturbance 11. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal 12. Ocular trauma within 6 months prior to Screening 13. Ocular surgery or any ocular laser treatment within 6 months prior to Screening. Any history of radial keratotomy is prohibited 14. 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 15. Monofocal IOL in place \> 6 months prior to Screening with any posterior capsule opacification 16. 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.) 17. 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: 18. 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) 19. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent 20. 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 21. 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 22. Participation in any investigational study within 30 days prior to Screening 23. Females 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, hormonal contraception (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. A female is considered to be of childbearing potential unless she is 1 year postmenopausal or 3 months post-surgical sterilization. All females of childbearing potential, including those with post-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening) 24. Resting HR outside the range of 50 to 110 beats per min (bpm) following at least a 5 min rest period in the sitting position at Visit 1 (Screening). HR may be repeated only once if outside the specified range, following another 5 min rest period in the sitting position 25. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg following at least a 5-min rest period in the sitting position at Visit 1 (Screening). BP may be repeated only once if outside the specified range, following another 5-min rest period in the sitting position

Contacts and Locations

Sponsors and CollaboratorsOcuphire Pharma, Inc.
Locations
Arizona Eye Center | Chandler Arizona, United States, 85224Carrot Eye Center | Mesa Arizona, United States, 85202Eye Doctors of Arizona | Phoenix Arizona, United States, 85028MRB Eye Care Consultants, LLC | Scottsdale Arizona, United States, 85260Empire Eye & Laser Center | Bakersfield California, United States, 93309Global Research Management, Inc. | Glendale California, United States, 91204Gordon Schanzlin New Vision Institute | La Jolla California, United States, 92307LoBue Laser and Eye Medical Center, Inc. | Murrieta California, United States, 92562Eye Research Foundation | Newport Beach California, United States, 92663Wolstan and Goldberg Eye Associates | Torrance California, United States, 90505Segal Drug Trials, Inc. | Delray Beach Florida, United States, 33484South Florida Glaucoma | Delray Beach Florida, United States, 33484Levenson Eye | Jacksonville Florida, United States, 32204Bowden Eye & Associates | Jacksonville Florida, United States, 32256Shettle Eye Research | Largo Florida, United States, 33773Sabal Eye Care/dba Omega Vision Center | Longwood Florida, United States, 32779Mid Florida Eye Center | Mt. Dora Florida, United States, 32757Virdi Eye Clinic | Rock Island Illinois, United States, 61201Price Vision Group | Indianapolis Indiana, United States, 46260Durrie Vision | Overland Park Kansas, United States, 66210Kannarr Eye Care | Pittsburg Kansas, United States, 66762Heart of America Eye Care, P.A. | Shawnee Mission Kansas, United States, 66204The Eye Care Institute | Louisville Kentucky, United States, 40206Fraser Eye Care Center | Fraser Michigan, United States, 48026Moyes Eye Center | Kansas City Missouri, United States, 64154Rochester Ophthalmological Group | Rochester New York, United States, 14618Oculus Research , Inc. | Garner North Carolina, United States, 27529Bergstrom Eye | Fargo North Dakota, United States, 58103Red River Research Partners | Fargo North Dakota, United States, 58103Athens Eye Care | Athens Ohio, United States, 45701West Bay Eye Associates | Warwick Rhode Island, United States, 02888Advancing Vision Research | Goodlettsville Tennessee, United States, 37072Optometry Group | Memphis Tennessee, United States, 38111Total Eye Care | Memphis Tennessee, United States, 38119Whitsett Vision Group | Houston Texas, United States, 77055Lake Travis Eye and Laser Center/ Revolution Research | Lakeway Texas, United States, 78738Red River Research Partners | Richardson Texas, United States, 75080Parkhurst NuVision | San Antonio Texas, United States, 78229Eye Institute of Utah | Salt Lake City Utah, United States, 84107
Investigators
Study Chair: Jay V Pepose, MD, Ocuphire Pharma