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Alpha-1 Adrenergic Receptor Antagonist

Nyxol Eye Drops + Low-Dose Pilocarpine Eye Drops for Presbyopia (VEGA-2 Trial)

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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 30 min post-ldp/vehicle comparing nyxol + ldp to nyxol alone at visit 5 (stage 2 day 8)
Awards & highlights
Pivotal Trial

Summary

This trial is testing Nyxol alone and with low dose pilocarpine to help people with presbyopia see better up close. The medications work by helping the eye focus better on nearby objects.

Eligible Conditions
  • Presbyopia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 30 min post-ldp/vehicle comparing nyxol + ldp to nyxol alone at visit 5 (stage 2 day 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 min post-ldp/vehicle comparing nyxol + ldp to nyxol alone at visit 5 (stage 2 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
Percent of subjects with ≥ 15 letters of improvement in photopic binocular DCNVA and with < 5 letters of loss in photopic binocular BCDVA in Nyxol-treated subjects
Secondary study objectives
Change and percent change in mesopic PD from Baseline
Change and percent change in photopic PD from Baseline
Change in mesopic binocular DCNVA from Baseline
+14 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo + low dose pilocarpine vehicleExperimental Treatment2 Interventions
Group II: Placebo + low dose pilocarpineExperimental Treatment2 Interventions
Group III: Nyxol + low dose pilocarpine vehicleExperimental Treatment2 Interventions
Group IV: Nyxol + low dose pilocarpineExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phentolamine Opthalmic Solution 0.75%
2022
Completed Phase 3
~340
Low dose pilocarpine
2022
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Ocuphire Pharma, Inc.Lead Sponsor
12 Previous Clinical Trials
1,873 Total Patients Enrolled
2 Trials studying Presbyopia
695 Patients Enrolled for Presbyopia

Media Library

Phentolamine Ophthalmic Solution 0.75% (Alpha-1 Adrenergic Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05646719 — Phase 3
Presbyopia Research Study Groups: Placebo + low dose pilocarpine vehicle, Placebo + low dose pilocarpine, Nyxol + low dose pilocarpine vehicle, Nyxol + low dose pilocarpine
Presbyopia Clinical Trial 2023: Phentolamine Ophthalmic Solution 0.75% Highlights & Side Effects. Trial Name: NCT05646719 — Phase 3
Phentolamine Ophthalmic Solution 0.75% (Alpha-1 Adrenergic Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05646719 — Phase 3
Presbyopia Patient Testimony for trial: Trial Name: NCT05646719 — Phase 3
~118 spots leftby Nov 2025
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