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Completed Phase 3 Interventional Accepts healthy volunteers

Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults

ClinicalTrials.gov ID: NCT04657172

Public ClinicalTrials.gov record NCT04657172. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:22 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Study of the Safety and Efficacy of 1% and 2% Pilocarpine Ophthalmic Solutions Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 3 treatment visits. At each treatment visit, 1 of the 3 study solutions is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.

Study identification

NCT ID
NCT04657172
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Eyenovia Inc.
Industry
Enrollment
84 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
40 Years to 60 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 15, 2020 (Actual)
Primary completion
Mar 26, 2021 (Actual)
Completion
Mar 26, 2021 (Actual)
Last update posted
Aug 9, 2021

2020 – 2021

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
9
Facility City State ZIP Site status
VISION-1 Study Site #21 Azusa California 91702 —
VISION-1 Study Site #52 Newport Beach California 92663 —
VISION-1 Study Site #54 Fort Collins Colorado 80528 —
VISION-1 Study Site #53 Orlando Florida 32803 —
VISION-1 Study Site #50 New York New York 10036 —
VISION-1 Study Site #17 High Point North Carolina 27262 —
VISION-1 Study Site #22 Raleigh North Carolina 27603 —
VISION-1 Study Site #51 Cranberry Township Pennsylvania 16066 —
VISION-1 Study Site #03 San Antonio Texas 78229 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04657172, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 9, 2021 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04657172 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →