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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 30 min post-ldp/vehicle comparing nyxol + ldp to nyxol alone at visit 5 (stage 2 day 8)
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)
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 moreAwards & 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy or cannot take medications that block alpha- and/or beta-adrenergic receptors.You have a known allergy or a medical reason that makes it unsafe for you to take certain medications that affect your nervous system.You are currently using any eye drops or medications for dry eyes.You have previously taken part in a study using Nyxol for treating presbyopia.You have had an eye injury in the past 6 months.You have a history of eye conditions that have affected your pupil or iris, either due to surgery, injury, or other non-traumatic causes.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo + low dose pilocarpine vehicle
- Group 2: Placebo + low dose pilocarpine
- Group 3: Nyxol + low dose pilocarpine vehicle
- Group 4: Nyxol + low dose pilocarpine
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Presbyopia Patient Testimony for trial: Trial Name: NCT05646719 — Phase 3