RECRUITING

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

Conditions

Vision Loss Night Vision Disorders keratorefractive surgery decreased visual acuity vision disorder mesopic lighting night vision

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WITH PREVIOUS KERATOREFRACTIVE SURGERY WITH DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS

Quick Facts

Study Start:2025-08

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07140783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Males or females ≥ 18 years of age 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	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 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

Inclusion Criteria

Exclusion Criteria

1. Males or females ≥ 18 years of age
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

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
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

Contacts and Locations

Study Contact

Sarah Callahan

CONTACT

919-260-5522

scallahan@opusgtx.com

Roselyn Judd

CONTACT

586-212-0237

roselyn.judd@oculoscr.com

Principal Investigator

Jay Pepose, MD

STUDY_CHAIR

Opus Genetics/Ocuphire Pharma

Study Locations (Sites)

Arizona Eye Care

Chandler, Arizona, 85224

United States

Carrot Eye Center

Mesa, Arizona, 85202

United States

Eye Doctors of Arizona

Phoenix, Arizona, 85028

United States

MRB Eye Care Consultants

Scottsdale, Arizona, 85254

United States

Global Research Management

Glendale, California, 91204

United States

Gordon Schanzlin New Vision

La Jolla, California, 92037

United States

Eye Research Foundation

Newport Beach, California, 92663

United States

California Eye Specialists Medical Group

Pasadena, California, 91107

United States

NVISION Clinical Research

San Diego, California, 92117

United States

Scripps Poway Eyecare and Optometry

San Diego, California, 92130

United States

Wolsten and Goldberg Eye Assoc.

Torrance, California, 90505

United States

Glaucoma Specialist of South Florida

Delray Beach, Florida, 33484

United States

Segal Drug Trials

Delray Beach, Florida, 33484

United States

Wyse Eyecare

Northbrook, Illinois, 60062

United States

Virdi Eye Clinic

Rock Island, Illinois, 61201

United States

Durrie Vision

Overland Park, Kansas, 66210

United States

Kannarr Eye Care

Pittsburg, Kansas, 66762

United States

Eye Health Vision Center

South Dartmouth, Massachusetts, 02747

United States

Northeast Eye Research Associates

Woburn, Massachusetts, 01801

United States

Oculus Research

Garner, North Carolina, 27529

United States

West Bay Eye Assoc.

Warwick, Rhode Island, 02888

United States

Zillan Clinical Research

Houston, Texas, 77082

United States

Hoopes Vision

Draper, Utah, 84020

United States

Collaborators and Investigators

Sponsor: Ocuphire Pharma, Inc.

Jay Pepose, MD, STUDY_CHAIR, Opus Genetics/Ocuphire Pharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08

Study Completion Date2026-03

Study Record Updates

Study Start Date2025-08

Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

keratorefractive surgery
decreased visual acuity
vision disorder
mesopic lighting
night vision

Additional Relevant MeSH Terms

Vision Loss Night
Vision Disorders