Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances
NCT ID: NCT06349759
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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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2024-04-01
2026-01-31
Brief Summary
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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
Daily dosing
phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Once daily dosing
phentolamine ophthalmic solution vehicle
Daily dosing
Placebo
Once daily dosing
Interventions
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phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
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 of refractive surgery (eg, PRK, LASIK, SMILE, and RK) and have subject-reported night vision disturbances (eg, glare, halos, and/or starbursts). Symptoms must have been first noted within 2 months following refractive 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 drops for dry eye, 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
8. Pseudophakic subjects 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) 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 or herpes zoster keratitis at Screening). Subjects 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
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 (eg, chronic obstructive pulmonary disease or bronchial asthma; abnormally low BP or HR; second- or third-degree heart blockage or congestive heart failure; or severe diabetes as defined below)
1. Predisposition to severe hypoglycemia (2 or more serious hypoglycemic episodes requiring assistance within 12 months prior to Screening)
2. Any hospitalization or emergency room visit due to poor diabetic control within 6 months prior to Screening
3. Currently untreated diabetes mellitus or previously untreated subjects who initiated oral anti-diabetic medication or insulin within 3 months prior to Screening
4. Any sign of diabetic retinopathy in either eye
17. Clinically significant systemic disease (eg, severe diabetes as previously defined, 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. 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 (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
21. 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
22. 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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Viatris Inc.
INDUSTRY
Ocuphire Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jay Pepose, MD
Role: STUDY_CHAIR
Ocuphire Pharma
Locations
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United States Phoenix
Phoenix, Arizona, United States
United States Scottsdale
Scottsdale, Arizona, United States
United States
Bakersfield, California, United States
United States, Glendale, CA
Glendale, California, United States
United States, LaJolla, CA
La Jolla, California, United States
United States, California
Newport Beach, California, United States
United States Rowland Heights
Rowland Heights, California, United States
United States Torrance
Torrance, California, United States
United States, Jacksonville, FL
Jacksonville, Florida, United States
United States Jacksonville
Jacksonville, Florida, United States
United States
Tampa, Florida, United States
United States Overland Park
Overland Park, Kansas, United States
United States Louisville
Louisville, Kentucky, United States
United States Fraser
Fraser, Michigan, United States
United States Smithtown
Smithtown, New York, United States
United States, North Carolina
Garner, North Carolina, United States
United States Fargo
Fargo, North Dakota, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, Mt Pleasant, SC
Mt. Pleasant, South Carolina, United States
United States Chattanooga
Chattanooga, Tennessee, United States
United States Smyrna
Smyrna, Tennessee, United States
United States Draper
Draper, Utah, United States
United States Lynchburg
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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OPI-NYXDLD-302 (LYNX-2)
Identifier Type: -
Identifier Source: org_study_id
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