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NCT04657172 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Presbyopia, sponsored by Eyenovia.

Completed
Registry status
Phase 3
Development phase
84
Enrollment target
9
Study locations

NCT04657172 is a Phase 3 study of Presbyopia that has completed, run by Eyenovia. The registered enrollment target is 84 participants, below the 268-participant average among 38 other Presbyopia trials with a reported enrollment target (69% lower). The trial reports 9 study locations across 7 states.

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The verdict

NCT04657172, a Phase 3 study of Presbyopia, has completed, sponsored by Eyenovia.

COMPLETED
Registry status
Phase 3
Development phase
84 participants
Enrollment target
9
Study locations

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Pilocarpine Ophthalmic

Study Locations (9)

California

  • VISION-1 Study Site #21 - Azusa
  • VISION-1 Study Site #52 - Newport Beach

North Carolina

  • VISION-1 Study Site #17 - High Point
  • VISION-1 Study Site #22 - Raleigh

Colorado

  • VISION-1 Study Site #54 - Fort Collins

Florida

  • VISION-1 Study Site #53 - Orlando

New York

  • VISION-1 Study Site #50 - New York

Pennsylvania

  • VISION-1 Study Site #51 - Cranberry Township

Texas

  • VISION-1 Study Site #03 - San Antonio

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2020-12-15
Est. Completion 2021-03-26
Phase Phase 3

Sponsor

Eyenovia

7 total trials

What the Registry Record Tells You About NCT04657172

The ClinicalTrials.gov registry entry for NCT04657172 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 268-participant average among 38 other Presbyopia trials with a reported enrollment target (69% lower). The listed sponsor is Eyenovia, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Presbyopia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04657172 reports 9 study locations spanning 7 distinct geographic areas - top geographies include California, North Carolina, Colorado.

Frequently Asked Questions

What is clinical trial NCT04657172 about?

NCT04657172 is a clinical study titled "Safety & Efficacy of Pilocarpine Eye Solutions for Temporary Improvement of Near Vision in Presbyopic Adults". 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...

What is the current status of trial NCT04657172?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2020-12-15. Estimated completion is 2021-03-26.

What conditions does trial NCT04657172 study?

This clinical trial studies the following conditions: Presbyopia.

What interventions are being tested in trial NCT04657172?

The interventions under investigation include: Placebo (DRUG), Pilocarpine Ophthalmic (DRUG).

Who is sponsoring clinical trial NCT04657172?

This trial is sponsored by Eyenovia, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04657172 being conducted?

This trial has 9 study locations across California, Colorado, Florida, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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