Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

NCT06349759 | Completed Phase 3 FDA Drug

• 1 other identifier: OPI-NYXDLD-302 (LYNX-2)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 25

Brief Summary

Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.

Conditions

Night Vision Loss; Mesopic Vision

Keywords

Low light vision

Outcome Measures

Primary Outcomes (1)

• Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15

  To evaluate the efficacy of POS to improve mLCVA in subjects with post-refractive surgery visual disturbances

  Day 15

Study Arms (2)

0.75% phentolamine ophthalmic solution

ACTIVE COMPARATOR

Daily dosing

Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist

phentolamine ophthalmic solution vehicle

PLACEBO COMPARATOR

Daily dosing

Drug: Placebo

Interventions

Placebo DRUG

Once daily dosing

Also known as: phentolamine ophthalmic solution vehicle

phentolamine ophthalmic solution vehicle

phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist DRUG

Once daily dosing

Also known as: Nyxol

0.75% phentolamine ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females ≥ 18 years of age
• 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
• Able to independently comply with all protocol-mandated procedures and to attend all scheduled office visits
• Able and willing to give written consent to participate in this study
• Able to self-administer study medication
• 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
• 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
• ≥ 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

You may not qualify if:

• Ophthalmic (in either eye):
• Prior unresolved dry eye diagnosis, taking prescription drops for dry eye, or taking artificial tear drops routinely for dry eye
• Prior history of fluctuating vision
• 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
• History or presence of corneal endothelial dystrophy (eg, Fuchs' dystrophy or presence of guttae)
• Known hypersensitivity to any topical alpha-adrenoceptor antagonists
• Known allergy or contraindication to any component of the vehicle formulation
• History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal
• Pseudophakic subjects with extended depth-of-focus or multifocal intraocular lenses (IOLs)
• Ocular trauma, ocular surgery (eg, IOLs), or laser procedure (eg, LASIK, PRK, SMILE, and RK) within 6 months prior to Screening
• 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.)
• 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
• History of diabetic retinopathy, diabetic macular edema, or dry or wet macular degeneration
• 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.)
• 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

Sponsors & Collaborators

• Ocuphire Pharma, Inc.: lead
• Viatris Inc.: collaborator

Study Sites (25)

United States Phoenix

Pheonix, Arizona, 85003, United States

Location

United States Scottsdale

Scottsdale, Arizona, 85260, United States

Location

United States

Bakersfield, California, 93309, United States

Location

United States, Glendale, CA

Glendale, California, 91204, United States

Location

United States, LaJolla, CA

La Jolla, California, 92903, United States

Location

United States, California

Newport Beach, California, 92663, United States

Location

United States Rowland Heights

Rowland Heights, California, 91748, United States

Location

United States Torrance

Torrance, California, 90505, United States

Location

United States, Jacksonville, FL

Jacksonville, Florida, 32256, United States

Location

United States Jacksonville

Jacksonville, Florida, 32257, United States

Location

United States

Tampa, Florida, 33603, United States

Location

United States Overland Park

Overland Park, Kansas, 66210, United States

Location

United States Louisville

Louisville, Kentucky, 40206, United States

Location

United States Fraser

Fraser, Michigan, 48026, United States

Location

United States

New York, New York, 10022, United States

Location

United States Smithtown

Smithtown, New York, 11787, United States

Location

United States, North Carolina

Garner, North Carolina, 27529, United States

Location

United States Fargo

Fargo, North Dakota, 58103, United States

Location

United States

Fargo, North Dakota, 58103, United States

Location

United States, Rhode Island

Warwick, Rhode Island, 02888, United States

Location

United States, Mt Pleasant, SC

Mt. Pleasant, South Carolina, 29464, United States

Location

United States Chattanooga

Chattanooga, Tennessee, 37411, United States

Location

United States Smyrna

Smyrna, Tennessee, 37167, United States

Location

United States Draper

Draper, Utah, 84020, United States

Location

United States Lynchburg

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Vitamin A Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jay Pepose, MD

  Ocuphire Pharma

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 1, 2024
• Primary Completion: April 17, 2025
• Study Completion: February 19, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-02

Locations

US (25)