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New eye drops could replace reading glasses for millions

NCT ID NCT05646719

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This Phase 3 trial tested Nyxol eye drops, alone or with low-dose pilocarpine, in 333 adults aged 40–64 with presbyopia (age-related difficulty seeing up close). The goal was to improve near vision without losing distance vision. Participants received drops and were measured after 30 minutes. If effective, this could offer a non-surgical alternative to reading glasses.

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) and low-dose pilocarpine hydrochloride ophthalmic solution 0.4%
What this could lead to
If successful, this could provide a simple eye drop treatment to help people with presbyopia see up close without reading glasses.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Eye drops may cause side effects like eye irritation or blurred distance vision, and the benefit may be modest or temporary.

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

333 people

The number who actually took part.

Started

Dec 2022

Finished

Oct 2023

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

40 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Males or females ≥ 40 and ≤ 64 years of age. 2. BCDVA of 0.1 LogMAR (20/25 Snellen equivalent) or better in each eye in photopic conditions. 3. DCNVA of 0.4 LogMAR (20/50 Snellen equivalent) or worse but not \> 0.7 LogMAR (20/100 Snellen equivalent) in photopic conditions in each eye and binocularly. 4. For subjects who depend on reading glasses or bifocals, binocular best-corrected near VA is 0.1 LogMAR (20/25 Snellen equivalent) or better. 5. Photopic PD of ≥ 3 mm in either eye. Exclusion Criteria: Ophthalmic (in either eye): 1. Use of any topical prescription 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 and artificial tears as specified in Exclusion # 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. Current use of any topical ophthalmic therapy for dry eye. 4. Tear break-up time of \< 5 seconds or corneal fluorescein staining Grade ≥ 2 in the inferior zone or Grade ≥ 1 in the central zone using the National Eye Institute scale.. 5. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator. 6. Recent or current evidence of ocular infection or inflammation in either eye. 7. Any history of herpes simplex or herpes zoster keratitis. 8. Known allergy, hypersensitivity, or contraindication to any component of the phentolamine, pilocarpine, or vehicle formulations. 9. Prior participation in a study involving the use of Nyxol for the treatment of presbyopia. 10. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal. 11. Ocular trauma within 6 months prior to Screening. 12. Ocular surgery or any ocular laser treatment within 6 months prior to Screening. 13. Subjects with surgical monovision, multifocal or extended depth of focus intraocular lenses (IOLs) are excluded. 14. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris. 15. Contact lens wear on the day of any study visit and contact lenses must be removed for home dosing and for at least 10 minutes following dosing. Systemic: 16. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists . 17. Known hypersensitivity or contraindication to any systemic cholinergic parasympathomimetic agent. 18. Clinically significant systemic disease that might interfere with the study as deemed by the judgment of the Investigator. 19. 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. 20. Participation in any investigational study within 30 days prior to Screening. 21. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. 22. Resting HR outside the range of 50 to 110 beats per min. 23. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg.

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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

  • Athens, OH

    Athens, Ohio, 45701, United States

  • Austin, TX

    Austin, Texas, 73301, United States

  • Azusa, CA

    Azusa, California, 91702, United States

  • Bloomington, MN

    Bloomington, Minnesota, 55420, United States

  • Chesterfield, MO

    Chesterfield, Missouri, 63017, United States

  • Cranberry Township, PA

    Cranberry Township, Pennsylvania, 16066, United States

  • Delray Beach, FL

    Delray Beach, Florida, 33484, United States

  • Fargo, ND

    Fargo, North Dakota, 58103, United States

  • Garner, NC

    Garner, North Carolina, 27529, United States

  • Houston, TX

    Houston, Texas, 77055, United States

  • Kansas City, MO

    Kansas City, Missouri, 64133, United States

  • Lake Villa, IL

    Lake Villa, Illinois, 60046, United States

  • Longwood, FL

    Longwood, Florida, 32779, United States

  • Memphis, TN

    Memphis, Tennessee, 38119, United States

  • New Freedom, PA

    New Freedom, Pennsylvania, 17349, United States

  • Newport Beach, CA

    Newport Beach, California, 92663, United States

  • Northridge, CA

    Northridge, California, 91325, United States

  • Phoenix, AZ

    Phoenix, Arizona, 85003, United States

  • Pittsburg, KS

    Pittsburg, Kansas, 66762, United States

  • Rochester, NY

    Rochester, New York, 14618, United States

  • Roswell, GA

    Roswell, Georgia, 30076, United States

  • Saint Louis, MO

    St Louis, Missouri, 63128, United States

  • San Antonio, TX

    San Antonio, Texas, 78229, United States

  • Shawnee Mission, KS

    Shawnee Mission, Kansas, 66204, United States

  • Sioux Falls, SD

    Sioux Falls, South Dakota, 57108, United States

  • Smithtown, NY

    Smithtown, New York, 11787, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.