RecruitingPhase 3NCT07140783

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

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


Sponsor

Ocuphire Pharma, Inc.

Enrollment

580 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 0.75% Phentolamine Ophthalmic Solution and a drug called Placebo for people with vision disorders and vision loss night. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG0.75% Phentolamine Ophthalmic Solution

Once daily dosing

DRUGPlacebo

Once daily dosing


Locations(20)

Arizona Eye Care

Chandler, Arizona, United States

Eye Doctors of Arizona

Phoenix, Arizona, United States

MRB Eye Care Consultants

Scottsdale, Arizona, United States

Global Research Management

Glendale, California, United States

Gordon Schanzlin New Vision

La Jolla, California, United States

Eye Research Foundation

Newport Beach, California, United States

California Eye Specialists Medical Group

Pasadena, California, United States

NVISION Clinical Research

San Diego, California, United States

Scripps Poway Eyecare and Optometry

San Diego, California, United States

Wolsten and Goldberg Eye Assoc.

Torrance, California, United States

Segal Drug Trials

Delray Beach, Florida, United States

Wyse Eyecare

Northbrook, Illinois, United States

Virdi Eye Clinic

Rock Island, Illinois, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Northeast Eye Research Associates

Woburn, Massachusetts, United States

Oculus Research

Garner, North Carolina, United States

Scott & Christie EyeCare Associates

Cranberry Township, Pennsylvania, United States

West Bay Eye Assoc.

Warwick, Rhode Island, United States

Zillan Clinical Research

Houston, Texas, United States

Hoopes Vision

Draper, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07140783


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