NCT06542497

Evaluate Efficacy and Safety of POS to Improve Distance-corrected Near Visual in Participants With Presbyopia

Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants With Presbyopia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 569 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 45 Years – 64 Years
• Healthy volunteers: Accepted

Summary

Safety and efficacy of POS in participants with presbyopia

Detailed description

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Efficacy and Safety of Phentolamine Ophthalmic Solution (POS) 0.75% in Participants with Presbyopia

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	0.75% phentolamine ophthalmic solution	Once daily dosing
DRUG	Placebo	Once daily dosing

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-04-03
• Completion: 2026-01-22
• First posted: 2024-08-07
• Last updated: 2026-03-12

Locations

39 sites across 1 country: United States

Regulatory

• FDA-regulated drug study