NCT06349759

Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

Randomized, Placebo-Controlled, Double-Masked Study of the Safety and Efficacy of POS (0.75% Phentolamine Ophthalmic Solution) in Subjects Who Have Previously Had Keratorefractive Surgery and Have Decreased Visual Acuity Under Mesopic Conditions

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

Summary

Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.

Detailed description

Randomized, placebo-controlled, double-masked study of the safety and efficacy of POS (0.75% Phentolamine Ophthalmic Solution) in subjects who have previously had keratorefractive surgery and have decreased visual acuity (VA) under mesopic conditions

Conditions

• Mesopic Vision
• Night Vision Loss

Interventions

Type	Name	Description
DRUG	phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist	Once daily dosing
DRUG	Placebo	Once daily dosing

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-04-17
• Completion: 2026-02-19
• First posted: 2024-04-05
• Last updated: 2026-03-12

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study