NCT05646719

Safety and Efficacy of Nyxol Eye Drops as a Single Agent and With Adjunctive Low-Dose Pilocarpine Eye Drops in Subjects With Presbyopia

Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: Ocuphire Pharma, Inc. · Industry
• Sex: All
• Age: 40 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are: To evaluate the safety and efficacy of Nyxol alone and with adjunctive low dose pilocarpine to improve distance-corrected near visual acuity (DCNVA) in subjects with presbyopia.

Detailed description

This is a Randomized, Double-Masked, Placebo-Controlled, Multicenter, Phase 3 Study of the Safety and Efficacy of Nyxol (Phentolamine Ophthalmic Solution 0.75%) as a Single Agent and With Adjunctive Low-Dose Pilocarpine Hydrochloride Ophthalmic Solution 0.4% in Subjects With Presbyopia

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	Phentolamine Opthalmic Solution 0.75%	phentolamine ophthalmic solution 0.75% (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
OTHER	Placebo	Vehicle for Phentolamine Ophthalmic Solution
DRUG	Low dose pilocarpine	Pilocarpine hydrochloride ophthalmic solution 0.4%
OTHER	Low dose pilocarpine vehicle	Vehicle for low dose pilocarpine

Timeline

• Start date: 2022-12-22
• Primary completion: 2023-10-11
• Completion: 2023-10-11
• First posted: 2022-12-12
• Last updated: 2026-03-12
• Results posted: 2025-06-03

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study