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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Ocuphire Pharma, Inc.
Study ID
NCT07140783
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Vision Disorders
  • Vision Loss Night

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 0.75% Phentolamine Ophthalmic Solution — DRUG
    Once daily dosing
  • Placebo — DRUG
    Once daily dosing

Study Details

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

Key Dates

First listed
Aug 26, 2025
Start date
Sep 2, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 0.75% Phentolamine Ophthalmic Solution
    0.75% Phentolamine Ophthalmic Solution
  • Placebo Comparator: Placebo - Phentolamine Ophthalmic Solution vehicle
    Placebo-phentolamine ophthalmic solution vehicle

Primary Outcome Measure

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 [ Time Frame: Day 15 ]

Locations (23)

FacilityCityStateZIPSite coordinators
Arizona Eye CareChandlerArizona85224-
Carrot Eye CenterMesaArizona85202-
Eye Doctors of ArizonaPhoenixArizona85028-
MRB Eye Care ConsultantsScottsdaleArizona85254-
Global Research ManagementGlendaleCalifornia91204-
Gordon Schanzlin New VisionLa JollaCalifornia92037-
Eye Research FoundationNewport BeachCalifornia92663-
California Eye Specialists Medical GroupPasadenaCalifornia91107-
NVISION Clinical ResearchSan DiegoCalifornia92117-
Scripps Poway Eyecare and OptometrySan DiegoCalifornia92130-
Wolsten and Goldberg Eye Assoc.TorranceCalifornia90505-
Glaucoma Specialist of South FloridaDelray BeachFlorida33484-
Segal Drug TrialsDelray BeachFlorida33484-
Wyse EyecareNorthbrookIllinois60062-
Virdi Eye ClinicRock IslandIllinois61201-
Durrie VisionOverland ParkKansas66210-
Kannarr Eye CarePittsburgKansas66762-
Eye Health Vision CenterRussells MillsMassachusetts02747-
Northeast Eye Research AssociatesWoburnMassachusetts01801-
Oculus ResearchGarnerNorth Carolina27529-
West Bay Eye Assoc.WarwickRhode Island02888-
Zillan Clinical ResearchHoustonTexas77082-
Hoopes VisionDraperUtah84020-

Find similar trials in Chandler, AZ

By research site
Arizona Eye Care· Chandler, AZCarrot Eye Center· Mesa, AZEye Doctors of Arizona· Phoenix, AZMRB Eye Care Consultants· Scottsdale, AZGlobal Research Management· Glendale, CAGordon Schanzlin New Vision· La Jolla, CA

Related Studies