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New eye drops aim to banish night glare after laser surgery

NCT ID NCT07140783

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether phentolamine eye drops can improve vision in low light for people who had laser eye surgery and now see glare, halos, or starbursts at night. About 200 adults will use the drops or a placebo every evening for two weeks. The main goal is to see if more people gain a meaningful improvement in low-light vision compared to placebo.

What this could mean

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

Active substance
phentolamine eye drops
What this could lead to
If it works, this could offer a daily eye drop to reduce night vision problems like glare and halos after laser eye surgery.
What could go wrong
This is a Phase 3 trial, but the treatment is only tested for 2 weeks. It may not work for everyone, and long-term safety is unknown.
Why investors are watching

Ocuphire Pharma runs a Phase 3 trial of Phentolamine Ophthalmic Solution in 580 adults who had keratorefractive surgery and have decreased visual acuity in low light. The trial compares the drug to a placebo drop over two weeks. A company this small depends on a clear result from a late-stage trial to move its lead program forward.

If it works: If the drug improves vision in low light better than placebo, Ocuphire could point to a positive late-stage result for its lead eye drop and take the next step toward seeking approval.

If it fails: If the drug does not beat placebo, or if the trial is delayed, Ocuphire has limited resources to fall back on. Most Phase 3 trials fail, and a miss would set the program back.

AI-written from the trial record. Speculative, and not investment advice.

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

About 580 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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

18 years and older

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 ≥ 18 years of age 2. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits 3. Able and willing to give written consent to participate in this study 4. Able to self-administer study medication Inclusion criteria #5, #6, #7, and #8 must all be met in the same eye: 5. History of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy \[AK\]/limbal-relaxing incisions \[LRI\]) prior to 2010 in at least 1 eye and have participant reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following keratorefractive surgery. 6. This test may be repeated once, following an additional 5 min of dark adaptation to the mesopic light conditions if the initial results do not meet this criterion 7. mLCVA ≤ 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/63 Snellen or worse) in at least 1 eye using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m 8. ≥ 10 ETDRS letters improvement in mLCVA in at least 1 eye during illumination of the contralateral eye with a Brightness Acuity Tester (BAT) system on the low setting using the Precision Vision Illuminator Cabinet with 5% translucent contrast chart and a mesopic filter at 4 m Exclusion Criteria: Ophthalmic (in either eye unless otherwise noted): 1. Prior unresolved dry eye diagnosis, taking prescription medication for dry eye (eg, drops, nasal sprays \[Tyrvaya®\], etc.), or taking artificial tear drops routinely for dry eye 2. Prior history of fluctuating vision 3. Clinically significant ocular disease as deemed by the Investigator (eg, untreated visually significant cataract, glaucoma, corneal edema, uveitis, severe keratoconjunctivitis sicca, retina degeneration, loss of visual field due to glaucoma or stroke, branch retinal vein occlusion, retina flare) that might interfere with the study 4. History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae) 5. Known hypersensitivity to any topical alpha-adrenoceptor antagonists 6. Known allergy or contraindication to any component of the vehicle formulation 7. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal in the study eye 8. Pseudophakic participants with extended depth-of-focus or multifocal intraocular lenses (IOLs) 9. Ocular trauma, ocular surgery (eg, IOLs), or laser procedure (eg, LASIK, PRK, SMILE, and RK/AK/LRI) within 6 months prior to Screening 10. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind (including artificial tear drops) within 7 days prior to Screening until study completion, with the exception of lid scrubs with OTC products (eg, OCuSOFT® lid scrub, SteriLid®, baby shampoo, etc.) 11. Recent or current evidence of ocular infection or inflammation (such as current evidence of clinically significant blepharitis, conjunctivitis, or a history of herpes simplex keratitis or herpes zoster keratitis at Screening). Participants must be symptom free for at least 7 days prior to Screening 12. History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration in the study eye 13. 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, etc.) 14. 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 15. Previously undiagnosed dry eye, at the determination of the Investigator. Dry eye diagnosis should be based on one of the following dry eye test results: tear break-up time \< 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 Systemic: 16. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists 17. Clinically significant systemic disease (eg, severe diabetes, myasthenia gravis, cancer, hepatic, renal, endocrine, or cardiovascular disorders) that might interfere with the study 18. 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 19. Participation in any investigational study within 30 days prior to Screening or during the study 20. Participation in any other investigational study using POS 21. Females of childbearing potential who are pregnant, nursing, planning a pregnancy during the study, 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 \< 3 months post-tubal ligation, must have a negative urine pregnancy test result at Screening to enroll in the study 22. Resting HR outside 50 to 110 beats per min at Screening. HR may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position 23. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg at Screening. BP may be repeated only once if outside the specified range, following at least a 5-min rest period in the sitting position

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Eye Care

    RECRUITING

    Chandler, Arizona, 85224, United States

  • California Eye Specialists Medical Group

    RECRUITING

    Pasadena, California, 91107, United States

  • Eye Doctors of Arizona

    RECRUITING

    Phoenix, Arizona, 85028, United States

  • Eye Research Foundation

    RECRUITING

    Newport Beach, California, 92663, United States

  • Global Research Management

    RECRUITING

    Glendale, California, 91204, United States

  • Gordon Schanzlin New Vision

    RECRUITING

    La Jolla, California, 92037, United States

  • Hoopes Vision

    RECRUITING

    Draper, Utah, 84020, United States

  • Kannarr Eye Care

    RECRUITING

    Pittsburg, Kansas, 66762, United States

  • MRB Eye Care Consultants

    RECRUITING

    Scottsdale, Arizona, 85254, United States

  • NVISION Clinical Research

    RECRUITING

    San Diego, California, 92117, United States

  • Northeast Eye Research Associates

    RECRUITING

    Woburn, Massachusetts, 01801, United States

  • Oculus Research

    RECRUITING

    Garner, North Carolina, 27529, United States

  • Scott & Christie EyeCare Associates

    RECRUITING

    Cranberry Township, Pennsylvania, 16066, United States

  • Scripps Poway Eyecare and Optometry

    RECRUITING

    San Diego, California, 92130, United States

  • Segal Drug Trials

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Virdi Eye Clinic

    RECRUITING

    Rock Island, Illinois, 61201, United States

  • West Bay Eye Assoc.

    RECRUITING

    Warwick, Rhode Island, 02888, United States

  • Wolsten and Goldberg Eye Assoc.

    RECRUITING

    Torrance, California, 90505, United States

  • Wyse Eyecare

    RECRUITING

    Northbrook, Illinois, 60062, United States

  • Zillan Clinical Research

    RECRUITING

    Houston, Texas, 77082, United States

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