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Alpha-adrenergic antagonist

Phentolamine Eye Drops for Presbyopia (VEGA-3 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
Able to self-administer study medication throughout the study period
Males or females aged 45 to 64
Must not have
Use of any OTC artificial tears during visit days or 15 min before or after instillation of study medication
Clinically significant ocular disease that might interfere with study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 8
Awards & highlights

Summary

This trial will test the safety and effectiveness of a new treatment for presbyopia.

Who is the study for?
This trial is for people aged 45-64 with presbyopia, who rely on reading glasses or bifocals. They must have certain levels of visual acuity and pupil diameter, be able to self-administer medication, and attend all visits. Pregnant women, those with significant eye diseases or systemic diseases, contact lens users, and individuals allergic to the study's components cannot participate.
What is being tested?
The trial is testing the safety and effectiveness of a 0.75% phentolamine ophthalmic solution (POS) compared to a placebo in improving near vision for people with presbyopia. Participants will receive either POS or a placebo without knowing which one they are getting.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include typical reactions associated with ophthalmic solutions such as eye irritation, redness, discomfort or allergic reactions. The study aims to assess these outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take my own medication during the study.
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I am between 45 and 64 years old.
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I can follow all study rules and attend all appointments by myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use over-the-counter artificial tears during study visits.
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I do not have any eye conditions that could affect the study.
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I have had eye surgery or have an eye condition.
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I started a new medication less than a week ago or will start one during the study.
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I am not pregnant, nursing, planning to become pregnant, and I use effective birth control.
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I haven't used any dry eye products in the last year.
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My eyes dry up quickly or have significant staining.
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I currently have or recently had an eye infection or inflammation.
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My heart rate was not between 50 and 110 bpm during my first visit.
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My blood pressure was over 160/105 mmHg at my first visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary efficacy endpoint

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: 0.75% phentolamine ophthalmic solutionActive Control1 Intervention
Drug: phentolamine ophthalmic solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist
Group II: phentolamine ophthalmic solution vehiclePlacebo Group1 Intervention
Drug: Placebo

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Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
12 Previous Clinical Trials
1,661 Total Patients Enrolled
2 Trials studying Presbyopia
483 Patients Enrolled for Presbyopia
Jay V Pepose, MDStudy ChairOcuphire Pharma
~363 spots leftby Oct 2025
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