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Eye drops could brighten your night vision

NCT ID NCT04638660

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether Nyxol eye drops can help people who have trouble seeing in dim light, often after eye surgeries like LASIK or cataract surgery. 144 adults received either the eye drops or a placebo for 8 days. The main goal was to see if Nyxol could improve vision in low light by at least 3 lines on an eye chart.

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 (Nyxol)
What this could lead to
If it works, this could offer a simple eye drop to help people see better in dim light, especially after eye surgeries or injuries.
What could go wrong
This is a small, early-phase trial with only 144 participants. The improvement may be modest, and long-term safety is not yet known.

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

144 people

The number who actually took part.

Started

Dec 2020

Finished

May 2022

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. Subject-reported DLD (likely subjects with a history of multifocal IOLs, post-laser-assisted in situ keratomileusis \[LASIK\], corneal scars, and keratoconus) 3. Ability to comply with all protocol-mandated procedures independently and to attend all 4. Otherwise healthy and well-controlled subjects 5. Able and willing to give written consent to participate in this study 6. Able to self-administer study medication 7. PD ≥ 6 mm under mesopic conditions (prior to illumination) in at least one eye 8. ≤ 20 (20/100 Snellen or worse) ETDRS letters in mLCVA score 9. ≥10 ETDRS letters ( ≥2 lines) improvement in mLCVA in at least one eye during illumination of the contralateral eye with a BAT system on low setting Exclusion Criteria: Ophthalmic: 1. Prior history of dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops occasionally for dry eye 2. Prior history of fluctuating vision 3. Clinically significant ocular disease as deemed by the Investigator that might interfere with the study 4. Known hypersensitivity to any topical alpha-adrenoceptor antagonists 5. Known allergy or contraindication to any component of the vehicle formulation 6. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal 7. Ocular trauma, ocular surgery (e.g., IOLs) or laser procedure (e.g., LASIK, photorefractive keratectomy \[PRK\]) within 6 months prior to screening 8. Use of any topical prescription or over-the-counter (OTC) ophthalmic medications of any kind within 7 days of screening 9. Recent or current evidence of ocular infection or inflammation in either eye. Subjects must be symptom free for at least 7 days. 10. History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration 11. History of any traumatic (surgical or nonsurgical) or nontraumatic condition affecting the pupil or iris 12. Unwilling or unable to discontinue use of contact lenses at screening until study completion, except for keratoconus subjects who may wear contacts up to 24 hours prior to their scheduled visits Systemic: 1. Known hypersensitivity or contraindication to alpha- and/or beta-adrenoceptor antagonists 2. Clinically significant systemic disease that might interfere with the study 3. 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 4. Participation in any investigational study within 30 days prior to screening and during the conduct of the study 5. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control 6. Resting HR outside the specified range (50-110 beats per minute) 7. Hypertension with resting diastolic BP \> 105 mmHg or systolic BP \> 160 mmHg

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Conditions

The condition(s) this trial relates to.

night blindness

As listed by the trial registrant

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

Dim light vision disturbances

Contacts and locations

Locations

  • Clinical Site 1

    Petaluma, California, 94954, United States

  • Clinical Site 10

    Palisades Park, New Jersey, 07650, United States

  • Clinical Site 11

    Memphis, Tennessee, 38119, United States

  • Clinical Site 13

    Pittsburg, Kansas, 66762, United States

  • Clinical Site 14

    Louisville, Kentucky, 41008, United States

  • Clinical Site 18

    Jacksonville, Florida, 32256, United States

  • Clinical Site 19

    Ogden, Utah, 84403, United States

  • Clinical Site 2

    Fargo, North Dakota, 58103, United States

  • Clinical Site 20

    Edgewood, Kentucky, 41017, United States

  • Clinical Site 22

    High Point, North Carolina, 27262, United States

  • Clinical Site 3

    Jacksonville, Florida, 32204, United States

  • Clinical Site 4

    Elizabeth City, North Carolina, 27909, United States

  • Clinical Site 5

    San Antonio, Texas, 78240, United States

  • Clinical Site 6

    Newport Beach, California, 92663, United States

  • Clinical Site 8

    Pennington, New Jersey, 08534, United States

  • Clinical Site 9

    High Point, North Carolina, 27262, United States

  • Clinical Test 15

    Warwick, Rhode Island, 57108, United States