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Alpha-Adrenergic Blocker

Phentolamine Ophthalmic Solution 0.75% for Night Blindness

Phase 3
Waitlist Available
Research Sponsored by Ocuphire Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 days
Awards & highlights

Study Summary

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

Eligible Conditions
  • Night Blindness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Subjects With 3 Lines mLCVA Improvement in Study Eye
Secondary outcome measures
Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Percent Change From Baseline in Study Eye Mesopic Pupil Diameter (PD)
Percent of Subjects With Photopic Low Contrast Visual Acuity (pLCVA) and mHCVA Improvement in Study Eye
+1 more
Other outcome measures
Change and percent change in total RMS error and higher-order RMS

Side effects data

From 2021 Phase 3 trial • 185 Patients • NCT04620213
9%
Instillation site discomfort
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phentolamine Ophthalmic Solution Vehicle
Phentolamine Ophthalmic Solution 0.75%

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phentolamine Ophthalmic Solution 0.75%Experimental Treatment1 Intervention
One drop in both eyes at or near bedtime (8PM to 10PM)
Group II: Phentolamine Ophthalmic Solution VehiclePlacebo Group1 Intervention
One drop in both eyes at or near bedtime (8PM to 10PM)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentolamine Ophthalmic Solution 0.75%
2021
Completed Phase 3
~870

Find a Location

Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
11 Previous Clinical Trials
1,517 Total Patients Enrolled
1 Trials studying Night Blindness
200 Patients Enrolled for Night Blindness

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances
2020. "Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) in Subjects With Dim Light Vision Disturbances". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04638660.
~34 spots leftby Apr 2025
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