OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity

NCT07140783 | Recruiting Phase 3 FDA Drug

• 1 other identifier: OPI-NYXDLD-303 (LYNX-3)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 23

Brief Summary

The goal of this clinical trial is to learn if Phentolamine Ophthalmic Solution works to treat adults that have had keratorefractive surgery and have decreased visual acuity under mesopic conditions. It will also learn about the safety of Phentolamine Ophthalmic Solution. The main questions it aims to answer are: 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

Conditions

Vision Loss Night; Vision Disorders

Keywords

keratorefractive surgery; decreased visual acuity; vision disorder; mesopic lighting; night vision

Outcome Measures

Primary Outcomes (1)

• Percent of participants with >= 15 ETDRS letters (>= 3 lines) improvement in the study eye in mLCVA compared to Baseline (Day1 pre-dose) at Day 15

  To evaluate the efficacy of POS to improve mLCVA in subjects with previous keratorefractive surgery

  Day 15

Study Arms (2)

0.75% Phentolamine Ophthalmic Solution

EXPERIMENTAL

0.75% Phentolamine Ophthalmic Solution

Drug: 0.75% Phentolamine Ophthalmic Solution

Placebo - Phentolamine Ophthalmic Solution vehicle

PLACEBO COMPARATOR

Placebo-phentolamine ophthalmic solution vehicle

Drug: Placebo

Interventions

0.75% Phentolamine Ophthalmic Solution DRUG

Once daily dosing

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

0.75% Phentolamine Ophthalmic Solution

Placebo DRUG

Once daily dosing

Also known as: POS vehicle placebo

Placebo - Phentolamine Ophthalmic Solution vehicle

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 (\>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
• 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 unless otherwise noted):
• 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
• 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 in the study eye
• Pseudophakic participants 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/AK/LRI) 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 keratitis or herpes zoster keratitis at Screening). Participants 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 in the study eye
• 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

Study Sites (23)

Arizona Eye Care

Chandler, Arizona, 85224, United States

RECRUITING

Carrot Eye Center

Mesa, Arizona, 85202, United States

RECRUITING

Eye Doctors of Arizona

Phoenix, Arizona, 85028, United States

RECRUITING

MRB Eye Care Consultants

Scottsdale, Arizona, 85254, United States

RECRUITING

Global Research Management

Glendale, California, 91204, United States

RECRUITING

Gordon Schanzlin New Vision

La Jolla, California, 92037, United States

RECRUITING

Eye Research Foundation

Newport Beach, California, 92663, United States

RECRUITING

California Eye Specialists Medical Group

Pasadena, California, 91107, United States

RECRUITING

NVISION Clinical Research

San Diego, California, 92117, United States

RECRUITING

Scripps Poway Eyecare and Optometry

San Diego, California, 92130, United States

RECRUITING

Wolsten and Goldberg Eye Assoc.

Torrance, California, 90505, United States

RECRUITING

Glaucoma Specialist of South Florida

Delray Beach, Florida, 33484, United States

RECRUITING

Segal Drug Trials

Delray Beach, Florida, 33484, United States

RECRUITING

Wyse Eyecare

Northbrook, Illinois, 60062, United States

RECRUITING

Virdi Eye Clinic

Rock Island, Illinois, 61201, United States

RECRUITING

Durrie Vision

Overland Park, Kansas, 66210, United States

RECRUITING

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

RECRUITING

Eye Health Vision Center

South Dartmouth, Massachusetts, 02747, United States

RECRUITING

Northeast Eye Research Associates

Woburn, Massachusetts, 01801, United States

RECRUITING

Oculus Research

Garner, North Carolina, 27529, United States

RECRUITING

West Bay Eye Assoc.

Warwick, Rhode Island, 02888, United States

RECRUITING

Zillan Clinical Research

Houston, Texas, 77082, United States

RECRUITING

Hoopes Vision

Draper, Utah, 84020, United States

RECRUITING

MeSH Terms

Conditions

Vitamin A Deficiency; Vision Disorders

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jay Pepose, MD

  Opus Genetics/Ocuphire Pharma

  STUDY CHAIR

Central Study Contacts

Study Director

CONTACT

984-884-6030; ct.gov_inquiries@opusgtx.com

Study Design

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

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 26, 2025
• Study Start: September 2, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (23)