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

NCT04657172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-08-09

No results posted yet for this 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

Interventions

DRUG

Pilocarpine Ophthalmic

Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser

DRUG

Placebo

Vehicle ophthalmic solution administered with the Optejet microdose dispenser

Sponsors & Collaborators

  • Eyenovia Inc.

    lead INDUSTRY

Principal Investigators

  • Tsontcho (Sean) Ianchulev, MD, MPH · Eyenovia Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-03-26
Completion
2021-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657172 on ClinicalTrials.gov