Could these eye drops replace reading glasses? new trial tests a daily drop for aging eyes

NCT ID NCT06542497

Symptom relief Sponsor: Ocuphire Pharma, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This completed Phase 3 trial tested whether phentolamine eye drops (Nyxol) can improve near vision in people with presbyopia, the age-related loss of ability to focus on close objects. 569 adults aged 45 to 64 used the drops or a placebo once daily for 8 days. The main goal was to see if more people in the treatment group could read three lines better on a near-vision chart without losing distance vision, measured 12 hours after the last dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: phentolamine ophthalmic solution 0.75% (Nyxol)
What this could lead to: If it works, this could offer a daily eye drop to temporarily improve near vision for people with presbyopia, reducing the need for reading glasses.
What could go wrong: This is a completed Phase 3 trial, but results are not yet public. The effect may be modest or not work for everyone, and side effects like eye redness or headache are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

569 people

The number who actually took part.

Started

Aug 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 64 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

presbyopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Presbyopia

Contacts and locations

Locations

Advancing Vision Research

Goodlettsville, Tennessee, 37072, United States
Arizona Eye Center

Chandler, Arizona, 85224, United States
Athens Eye Care

Athens, Ohio, 45701, United States
Bergstrom Eye

Fargo, North Dakota, 58103, United States
Bowden Eye & Associates

Jacksonville, Florida, 32256, United States
Carrot Eye Center

Mesa, Arizona, 85202, United States
Durrie Vision

Overland Park, Kansas, 66210, United States
Empire Eye & Laser Center

Bakersfield, California, 93309, United States
Eye Doctors of Arizona

Phoenix, Arizona, 85028, United States
Eye Institute of Utah

Salt Lake City, Utah, 84107, United States
Eye Research Foundation

Newport Beach, California, 92663, United States
Fraser Eye Care Center

Fraser, Michigan, 48026, United States
Global Research Management, Inc.

Glendale, California, 91204, United States
Gordon Schanzlin New Vision Institute

La Jolla, California, 92307, United States
Heart of America Eye Care, P.A.

Shawnee Mission, Kansas, 66204, United States
Kannarr Eye Care

Pittsburg, Kansas, 66762, United States
Lake Travis Eye and Laser Center/ Revolution Research

Lakeway, Texas, 78738, United States
Levenson Eye

Jacksonville, Florida, 32204, United States
LoBue Laser and Eye Medical Center, Inc.

Murrieta, California, 92562, United States
MRB Eye Care Consultants, LLC

Scottsdale, Arizona, 85260, United States
Mid Florida Eye Center

Mt. Dora, Florida, 32757, United States
Moyes Eye Center

Kansas City, Missouri, 64154, United States
Oculus Research , Inc.

Garner, North Carolina, 27529, United States
Optometry Group

Memphis, Tennessee, 38111, United States
Parkhurst NuVision

San Antonio, Texas, 78229, United States
Price Vision Group

Indianapolis, Indiana, 46260, United States
Red River Research Partners

Fargo, North Dakota, 58103, United States
Red River Research Partners

Richardson, Texas, 75080, United States
Rochester Ophthalmological Group

Rochester, New York, 14618, United States
Sabal Eye Care/dba Omega Vision Center

Longwood, Florida, 32779, United States
Segal Drug Trials, Inc.

Delray Beach, Florida, 33484, United States
Shettle Eye Research

Largo, Florida, 33773, United States
South Florida Glaucoma

Delray Beach, Florida, 33484, United States
The Eye Care Institute

Louisville, Kentucky, 40206, United States
Total Eye Care

Memphis, Tennessee, 38119, United States
Virdi Eye Clinic

Rock Island, Illinois, 61201, United States
West Bay Eye Associates

Warwick, Rhode Island, 02888, United States
Whitsett Vision Group

Houston, Texas, 77055, United States
Wolstan and Goldberg Eye Associates

Torrance, California, 90505, United States

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