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Phentolamine Eye Drops for Night Vision Impairment (LYNX-2 Trial)

Phase 3
Recruiting
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 day 15
Awards & highlights

Summary

This trial tests if using a specific eye drop can help people who have vision problems after eye surgery.

Who is the study for?
This trial is for individuals experiencing night vision problems after refractive eye surgery. Participants should have stable post-surgery vision and no other ongoing eye conditions that could affect the study results.
What is being tested?
The trial tests if a special eye drop solution, Phentolamine Ophthalmic Solution at 0.75%, can improve low-light visual sharpness in people with night vision issues post-eye surgery, compared to a placebo (a substance with no active drug).
What are the potential side effects?
Potential side effects of Phentolamine may include brief stinging or burning sensation in the eyes upon application, possible headache, or uncommonly, an allergic reaction.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of subjects with an increase of at least 15 ETDRS letters read (≥ 3 lines) in the study eye in mLCVA compared to Baseline (Day 1 pre-dose) at Day 15

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 0.75% phentolamine ophthalmic solutionActive Control1 Intervention
Daily dosing
Group II: phentolamine ophthalmic solution vehiclePlacebo Group1 Intervention
Daily dosing

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Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
12 Previous Clinical Trials
2,006 Total Patients Enrolled
Viatris Inc.Industry Sponsor
9 Previous Clinical Trials
5,226 Total Patients Enrolled
Jay Pepose, MDStudy ChairOcuphire Pharma
1 Previous Clinical Trials
40 Total Patients Enrolled
~129 spots leftby Sep 2025
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