NCT07140783

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

OPI-NXYDLD-303 RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-MASKED STUDY OF THE SAFETY AND EFFICACY OF POS (0.75% PHENTOLAMINE OPHTHALMIC SOLUTION) IN PARTICIPANTS WHO HAVE PREVIOUSLY HAD KERATOREFRACTIVE SURGERY AND HAVE DECREASED VISUAL ACUITY UNDER MESOPIC CONDITIONS

Conditions

• Vision Loss Night
• Vision Disorders

Interventions

Type	Name	Description
DRUG	0.75% Phentolamine Ophthalmic Solution	Once daily dosing
DRUG	Placebo	Once daily dosing

Timeline

• Start date: 2025-09-02
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-08-26
• Last updated: 2025-10-01

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study