OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity
NCT ID: NCT07140783
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-09-02
2026-03-31
Brief Summary
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Researchers will compare Phentolamine Ophthalmic Solution to a placebo (a look-alike substance that contains no drug) to see if Phentolamine Ophthalmic Solution works to improve vision in low light conditions.
Participants will:
Take Phentolamine Ophthalmic Solution or a placebo drop every day for 2 weeks Visit the clinic once every week for 2 weeks for checkups and tests Keep a diary of when they instill the study medication each evening
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.75% Phentolamine Ophthalmic Solution
0.75% Phentolamine Ophthalmic Solution
0.75% Phentolamine Ophthalmic Solution
Once daily dosing
Placebo - Phentolamine Ophthalmic Solution vehicle
Placebo-phentolamine ophthalmic solution vehicle
Placebo
Once daily dosing
Interventions
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0.75% Phentolamine Ophthalmic Solution
Once daily dosing
Placebo
Once daily dosing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Previous history (\>6 months prior to Screening) of keratorefractive surgery (eg, PRK, LASIK, SMILE, and RK/astigmatic keratotomy \[AK\]/limbal-relaxing incisions \[LRI\]) in one or both eyes 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
3. Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
4. Able and willing to give written consent to participate in this study
5. Able to self-administer study medication
6. PD ≥ 5 mm under mesopic conditions in at least 1 eye. 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
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 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 post-tubal ligation, must have a negative urine pregnancy test result at each visit
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
18 Years
ALL
No
Sponsors
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Ocuphire Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Pepose, MD
Role: STUDY_CHAIR
Opus Genetics/Ocuphire Pharma
Locations
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Arizona Eye Care
Chandler, Arizona, United States
Carrot Eye Center
Mesa, Arizona, United States
Eye Doctors of Arizona
Phoenix, Arizona, United States
MRB Eye Care Consultants
Scottsdale, Arizona, United States
Global Research Management
Glendale, California, United States
Gordon Schanzlin New Vision
La Jolla, California, United States
Eye Research Foundation
Newport Beach, California, United States
California Eye Specialists Medical Group
Pasadena, California, United States
NVISION Clinical Research
San Diego, California, United States
Scripps Poway Eyecare and Optometry
San Diego, California, United States
Wolsten and Goldberg Eye Assoc.
Torrance, California, United States
Glaucoma Specialist of South Florida
Delray Beach, Florida, United States
Segal Drug Trials
Delray Beach, Florida, United States
Wyse Eyecare
Northbrook, Illinois, United States
Virdi Eye Clinic
Rock Island, Illinois, United States
Durrie Vision
Overland Park, Kansas, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Eye Health Vision Center
South Dartmouth, Massachusetts, United States
Northeast Eye Research Associates
Woburn, Massachusetts, United States
Oculus Research
Garner, North Carolina, United States
West Bay Eye Assoc.
Warwick, Rhode Island, United States
Zillan Clinical Research
Houston, Texas, United States
Hoopes Vision
Draper, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OPI-NYXDLD-303 (LYNX-3)
Identifier Type: -
Identifier Source: org_study_id
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