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

NCT05646719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2026-03-12

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-10-11
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05646719 on ClinicalTrials.gov