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Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances

NCT04638660 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2025-10-14

Study results available
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Summary

The objectives of this study are:

* To evaluate the efficacy of Nyxol to improve mesopic low contrast visual acuity (mLCVA) in subjects with Dim Light Vision Disturbances (DLD)
* To evaluate efficacy of Nyxol to improve visual performance
* To evaluate the safety of Nyxol

Conditions

  • Dim Light Vision Disturbances

Interventions

DRUG

Phentolamine Ophthalmic Solution 0.75%

0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist

DRUG

Phentolamine Ophthalmic Solution Vehicle (Placebo)

Topical sterile ophthalmic solution

Sponsors & Collaborators

  • Ocuphire Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-30
Primary Completion
2022-05-19
Completion
2022-05-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT04638660 on ClinicalTrials.gov