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Cholinergic Agonist

Pilocarpine 2% Ophthalmic Spray for Presbyopia (VISION-2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eyenovia 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 120 minutes post-dosing
Awards & highlights
Pivotal Trial

Summary

This trial involves volunteers who will use two different eye treatments. Participants must meet specific criteria to join. The study aims to test the effectiveness and safety of these treatments.

Eligible Conditions
  • Presbyopia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes post-dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes post-dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects gaining ≥ 15 letters in mesopic, high contrast, binocular distance corrected near visual acuity (DCNVA) with ≤ 5 letter loss in mesopic, high contrast, binocular distance visual acuity (DVA)

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pilocarpine 2% Ophthalmic SprayExperimental Treatment1 Intervention
2% pilocarpine ophthalmic spray administered with the Optejet dispenser
Group II: Placebo SprayPlacebo Group1 Intervention
Placebo ophthalmic spray administered with the Optejet dispenser
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pilocarpine Ophthalmic administered with the Optejet dispenser
2021
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

Eyenovia Inc.Lead Sponsor
8 Previous Clinical Trials
782 Total Patients Enrolled
1 Trials studying Presbyopia
84 Patients Enrolled for Presbyopia
Tsontcho (Sean) Ianchulev, MD, MPHStudy ChairEyenovia Inc.
3 Previous Clinical Trials
811 Total Patients Enrolled
1 Trials studying Presbyopia
84 Patients Enrolled for Presbyopia
~36 spots leftby Dec 2025
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